CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
Sponsor
MedImmune LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00659425
Collaborator
National Cancer Institute (NCI) (NIH)
57
5
10
75
11.4
0.2
Study Details
Study Description
Brief Summary
A dose-escalation study to estimate maximum cummulative dose (MTCD) of CAT-8015 that can be safely administered to a participant.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Children, Adolescents and Young Adults with Refractory CD22+ Acute Lymphoblastic Leukemia (ALL) or Non-Hodgkin Lymphoma (NHL) to estimate the maximum tolerated cummulative dose (MTCD), defined as the highest dose and number of doses that can be safely administered to a participant, and to establish a safe dose, based on the MTCD, for subsequent clinical testing.
Study Design
Study Type:
Interventional
Actual Enrollment
:
57 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Children, Adolescents and Young Adults With Refractory CD22+ Acute Lymphoblastic Leukemia (ALL) or Non-Hodgkin Lymphoma (NHL)
Study Start Date
:
Sep 1, 2008
Actual Primary Completion Date
:
Dec 1, 2014
Actual Study Completion Date
:
Dec 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 5 microgram per kilogram (mcg/kg) Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. |
Drug: CAT-8015 (Moxetumomab Pasudotox)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
| Experimental: 10 microgram per kilogram (mcg/kg) Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. |
Drug: CAT-8015 (Moxetumomab Pasudotox)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
| Experimental: 20 microgram per kilogram (mcg/kg): Schema A Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. |
Drug: CAT-8015 (Moxetumomab Pasudotox)
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
| Experimental: 20 microgram per kilogram (mcg/kg): Schema B Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. |
Drug: CAT-8015 (Moxetumomab Pasudotox)
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
| Experimental: 30 microgram per kilogram (mcg/kg): Schema A Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. |
Drug: CAT-8015 (Moxetumomab Pasudotox)
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
| Experimental: 30 microgram per kilogram (mcg/kg): Schema B Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. |
Drug: CAT-8015 (Moxetumomab Pasudotox)
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
| Experimental: 40 microgram per kilogram (mcg/kg): Schema B Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. |
Drug: CAT-8015 (Moxetumomab Pasudotox)
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
| Experimental: 32 microgram per kilogram (mcg/kg): Schema C Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
Drug: CAT-8015 (Moxetumomab Pasudotox)
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
| Experimental: 50 microgram per kilogram (mcg/kg): Schema B Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. |
Drug: CAT-8015 (Moxetumomab Pasudotox)
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
| Experimental: 50 microgram per kilogram (mcg/kg): Schema C Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
Drug: CAT-8015 (Moxetumomab Pasudotox)
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Dose Limiting Toxicities (DLTs) [Day 1 up to 21 days of Cycle 1 (each cycle duration was of 21 days)]
Adverse events that were suspected of a relationship to moxetumomab pasudotox and were greater than or equal to (>=) Grade 3 in severity were considered DLTs with the following additional criteria or exceptions: Participants with hematologic abnormalities of any grade, Grade 2 allergic reactions of bronchospasm or urticaria, or any Grade ≥ 3 allergic reaction, in the presence of premedication.
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [From start of study drug administration until 30 days after the last dose of study drug]
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
- Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) [From start of study drug administration until 30 days after the last dose of study drug]
Vital signs included parameters as heart rate, blood pressure, temperature, weight, pulse oximetry and respiratory rate. TEAEs were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug.
- Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) [From start of study drug administration up to 30 days after the last dose of study drug]
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with grade 3 or higher treatment-emergent adverse events (5% cut off) for laboratory abnormalities were reported as clinically relevant laboratory changes.
- Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants [From start of study drug administration up to 30 days after the last dose of study drug]
An abnormal chemistry finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
- Number of Participants With Abnormalities in Ophthalmologic Examination at End of Treatment That Were Not Present at Baseline [Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)]
Ophthalmologic examination included evaluation of retinal, corneal and lens abnormalities at baseline and end of treatment that were not present at screening. Participants who experienced abnormalitities during ophthalmologic examination recorded and reported.
- Number of Participants With Change From Baseline in Normal Sinus Rhythm Findings in ECG [Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)]
Number of participants with abnormal ECG changes (compared with baseline) as assessed by study cardiologist
- Change From Baseline to End of Treatment in Clinical Findings in Electrocardiogram (ECG) QT, QTC Interval and Ventricular Rate [Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)]
The 12-lead ECG data were summarized and evaluated for the following parameters: ,QT, QTC intervals and ventricular rate. Change from baseline in these parameters were reported.
- Best Overall Tumor Response [Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)]
Antitumor activity was assessed by best overall tumor response.
- Objective Response Rate (ORR) [Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)]
Objective response based on assessment of confirmed composite complete response (CRc) or partial response (PR) according to disease specific criteria [modified criteria for response in acute lymphoblastic leukemia (ALL)].
- Percentage of Participants With Relapse of Disease [Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)]
Relapse is defined as progressive disease (PD) following complete response (CR). Rate of relapse was only calculated for the subgroup of participants with complete response.
- Time to Disease Response [Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)]
Time to disease response was measured from the start of moxetumomab pasudotox administration to the first documentation of response (CR or PR) and was assessed in participants who achieved objective response.
- Duration of Response (DR) [Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment]
Duration of response was defined as the duration from the first documentation of objective response to the first documented disease progression.
- Time to Disease Progression (TDP) [Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment]
Time to disease progression was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression. Number of progressions were reported here.
- Progression-Free Survival (PFS) [Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)]
Progression-free survival was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression or death due to any cause, whichever occurs first. Number of progressions/deaths were reported here.
- Overall Survival (OS) [Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)]
Overall survival was determined as the time from the start of treatment with Moxetumomab Pasudotox until death. Number of deaths were reported here.
- Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox [Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6]
The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.
- Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUC [0 to Infinity]) for Moxetumomab Pasudotox [Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6]
The AUC (0 to infinity) is the area under the plasma concentration-time curve from time zero to infinity hours.
- Systemic Clearance (CL) for Moxetumomab Pasudotox [Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6]
The CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma area under the plasma concentration-time curve from time zone to infinite time (AUC[0-infinity]).
- Terminal Phase Elimination Half Life (t1/2) for Moxetumomab Pasudotox [Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Secondary Outcome Measures
- Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody [Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)]
Participants tested for immunogenicity to CAT-8015 (moxetumomab pasudotox) prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. It was used as a direct surrogate for biological activity based on the mechanism of action of this drug. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit greater than (>)50 percentage (%) of the binding of CAT-8015 to CD22 using an ELISA-based method.
- CD22 Expression Cells in Peripheral Blood by Best Response [Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)]
Participants malignant cells (peripheral blood) was tested for cluster of differentiation 22 (CD22) expression by fluorescence-activated cell sorter (FACS) analysis.
- Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS) [Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)]
Potential biomarkers include orthostatic blood pressure, albumin levels, weight change, edema and hypoxia were evaluated.
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Months
to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Histologically confirmed diagnosis of acute lymphoblastic leukemia (ALL) or non-Hodgkin's lymphoma (NHL) including lymphoblastic lymphoma, Burkitt's lymphoma, and large cell lymphoma; - Measurable or evaluable disease. - Evidence of CD22-positive malignancy by one of the following criteria: - greater than or equal to (>=) 30 % of malignant cells from a disease site cluster of differentiation 22+ (CD22+) by fluorescence-activated cell sorter (FACS) analysis or; ≥ 15 % of malignant cells from a disease site CD22+ by immunohistochemistry (IHC). Stage of disease: - Participants must have relapsed or refractory disease and have received at least one standard chemotherapy and one salvage regimen or allogeneic stem cell transplant; - Relapse after prior autologous or allogeneic HSCT is allowed. In the event of relapse after prior allogeneic HSCT, the participant must be at least 100 days post-transplant and have no evidence of ongoing active graft-vs-host disease; - Recovered from the acute toxic effects of all prior therapy before entry. Performance status: - Participants greater than or equal to (>=) 12 years of age: Eastern
Cooperative Oncology Group (ECOG) score of 0, 1, 2, or 3; - Participants < 12 years of age:
Lansky scale >= 50%; - Participants who are unable to walk because of paralysis, but who are up in a wheel chair will be considered ambulatory for the purpose of calculating the performance score. Participants with the following central nervous system (CNS) status, are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy. - Female and male participants with childbearing potential and their sexual partners must agree to use an approved method of contraception during the study.
Exclusion Criteria:
- Participants meeting any of the following criteria are not eligible for participation in the study: - Isolated testicular or CNS ALL; Hepatic function: - Inadequate liver function defined as total bilirubin > 2 × upper limit of normal (ULN) (except in the case of participants with documented Gilbert's disease > 5 × ULN) or transaminases (ALT and aspartate aminotransferase [AST]) > 5 × ULN based on age- and laboratory-specific normal ranges; Renal function: - With greater than age-adjusted normal serum creatinine (see Table below) and a creatinine clearance > 60 millilitre per minute mL/min/1.73 m2. - Age(Years)- Maximum Serum Creatinine (mg/dl)[≤5,0.8] [5 < age less than or equal to 10,1.0] [10 < age less than or equal to 15,1.2 [> 15, 1.5] Hematologic function: - For non-leukemic subjects only, absolute neutrophil count (ANC) < 1000/cmm, or platelet count < 50,000/cmm, if these cytopenias are not judged by the investigator to be due to underlying disease (ie potentially reversible with anti-neoplastic therapy); - Participants with CNS 3 disease; - Hyperleukocytosis (≥ 50,000 blasts/µL) or rapidly progressive disease (PD) that in the estimation of the investigator and sponsor would compromise ability to complete study therapy; - Prior treatment with CAT-3888 (BL22) or any pseudomonas-exotoxin-containing compound; - HIV positive serology (due to increased risk of severe infection and unknown interaction of CAT-8015 with antiretroviral drugs); - Active hepatitis B or C infection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Los Angeles | California | United States | |
| 2 | Research Site | Bethesda | Maryland | United States | |
| 3 | Research Site | Boston | Massachusetts | United States | |
| 4 | Research Site | Memphis | Tennessee | United States | |
| 5 | Research Site | Toronto | Ontario | Canada |
Sponsors and Collaborators
- MedImmune LLC
- National Cancer Institute (NCI)
Investigators
- Study Director: Medimmune LLC Medimmune LLC, MedImmune LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00659425
Other Study ID Numbers:
- CAT-8015-1004
First Posted:
Apr 16, 2008
Last Update Posted:
Oct 2, 2017
Last Verified:
Aug 1, 2017
Keywords provided by MedImmune LLC
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 57 participants were enrolled of which 55 participants received treatment. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Period Title: Overall Study | ||||||||||
| STARTED | 1 | 1 | 1 | 4 | 4 | 5 | 8 | 11 | 6 | 14 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| NOT COMPLETED | 1 | 1 | 1 | 4 | 4 | 4 | 8 | 11 | 6 | 13 |
Baseline Characteristics
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Total of all reporting groups |
| Overall Participants | 1 | 1 | 1 | 4 | 4 | 5 | 8 | 11 | 6 | 14 | 55 |
| Age (Years) [Mean (Standard Deviation) ] | |||||||||||
| Mean (Standard Deviation) [Years] |
17
(NA)
|
8
(NA)
|
17
(NA)
|
12.8
(6.8)
|
9
(2.7)
|
14
(4.7)
|
8.6
(5.3)
|
13.8
(6.3)
|
12.8
(8.3)
|
14.3
(5.5)
|
12.7
(5.9)
|
| Sex: Female, Male (Count of Participants) | |||||||||||
| Female |
1
100%
|
0
0%
|
0
0%
|
3
75%
|
0
0%
|
0
0%
|
3
37.5%
|
6
54.5%
|
2
33.3%
|
6
42.9%
|
21
38.2%
|
| Male |
0
0%
|
1
100%
|
1
100%
|
1
25%
|
4
100%
|
5
100%
|
5
62.5%
|
5
45.5%
|
4
66.7%
|
8
57.1%
|
34
61.8%
|
Outcome Measures
| Title | Number of Participants With Dose Limiting Toxicities (DLTs) |
|---|---|
| Description | Adverse events that were suspected of a relationship to moxetumomab pasudotox and were greater than or equal to (>=) Grade 3 in severity were considered DLTs with the following additional criteria or exceptions: Participants with hematologic abnormalities of any grade, Grade 2 allergic reactions of bronchospasm or urticaria, or any Grade ≥ 3 allergic reaction, in the presence of premedication. |
| Time Frame | Day 1 up to 21 days of Cycle 1 (each cycle duration was of 21 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Population for DLT included all participants who received any treatment of moxetumomab pasudotox (CAT-8015) and completed the DLT period without a DLT, or did not complete the DLT period due to a DLT. Here, "N" is number of participants evaluated for this outcome measure. |
| Arm/Group Title | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 3 | 4 | 3 | 7 | 7 | 3 | 11 |
| Number [participants] |
0
0%
|
0
0%
|
0
0%
|
2
50%
|
0
0%
|
1
20%
|
1
12.5%
|
0
0%
|
1
16.7%
|
| Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
|---|---|
| Description | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. |
| Time Frame | From start of study drug administration until 30 days after the last dose of study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population included all participants who received any treatment of study drug. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 1 | 4 | 4 | 5 | 8 | 11 | 6 | 14 |
| TEAEs |
1
100%
|
1
100%
|
1
100%
|
4
100%
|
4
100%
|
5
100%
|
8
100%
|
11
100%
|
6
100%
|
14
100%
|
| TESAEs |
1
100%
|
1
100%
|
1
100%
|
4
100%
|
3
75%
|
2
40%
|
5
62.5%
|
7
63.6%
|
4
66.7%
|
9
64.3%
|
| Title | Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) |
|---|---|
| Description | Vital signs included parameters as heart rate, blood pressure, temperature, weight, pulse oximetry and respiratory rate. TEAEs were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. |
| Time Frame | From start of study drug administration until 30 days after the last dose of study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population included all participants who received any treatment of study drug. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 1 | 4 | 4 | 5 | 8 | 11 | 6 | 14 |
| Tachycardia |
0
0%
|
0
0%
|
0
0%
|
2
50%
|
3
75%
|
3
60%
|
2
25%
|
2
18.2%
|
0
0%
|
3
21.4%
|
| Arrhythmia |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
| Bradycardia |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
1
20%
|
0
0%
|
1
9.1%
|
0
0%
|
1
7.1%
|
| Sinus bradycardia |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
9.1%
|
0
0%
|
0
0%
|
| Sinus tachycardia |
1
100%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
7.1%
|
| Pyrexia |
1
100%
|
0
0%
|
0
0%
|
2
50%
|
4
100%
|
2
40%
|
2
25%
|
2
18.2%
|
2
33.3%
|
7
50%
|
| Dyspnoea |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
1
9.1%
|
0
0%
|
4
28.6%
|
| Respiratory distress |
0
0%
|
0
0%
|
1
100%
|
0
0%
|
0
0%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
2
14.3%
|
| Tachypnoea |
0
0%
|
0
0%
|
0
0%
|
1
25%
|
1
25%
|
0
0%
|
1
12.5%
|
1
9.1%
|
0
0%
|
0
0%
|
| Hypertension |
0
0%
|
1
100%
|
0
0%
|
0
0%
|
2
50%
|
0
0%
|
1
12.5%
|
3
27.3%
|
1
16.7%
|
5
35.7%
|
| Hypotension |
0
0%
|
1
100%
|
0
0%
|
0
0%
|
1
25%
|
2
40%
|
2
25%
|
2
18.2%
|
1
16.7%
|
1
7.1%
|
| Title | Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) |
|---|---|
| Description | An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with grade 3 or higher treatment-emergent adverse events (5% cut off) for laboratory abnormalities were reported as clinically relevant laboratory changes. |
| Time Frame | From start of study drug administration up to 30 days after the last dose of study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received any treatment of study drug. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 1 | 4 | 4 | 5 | 8 | 11 | 6 | 14 |
| Febrile neutropenia |
0
0%
|
1
100%
|
1
100%
|
1
25%
|
2
50%
|
1
20%
|
3
37.5%
|
5
45.5%
|
0
0%
|
1
7.1%
|
| Anemia |
0
0%
|
1
100%
|
1
100%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
3
21.4%
|
| Leukopenia |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
20%
|
3
37.5%
|
0
0%
|
0
0%
|
1
7.1%
|
| Lymphopenia |
0
0%
|
1
100%
|
1
100%
|
0
0%
|
0
0%
|
1
20%
|
3
37.5%
|
0
0%
|
0
0%
|
1
7.1%
|
| Neutropenia |
0
0%
|
1
100%
|
0
0%
|
0
0%
|
0
0%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
1
7.1%
|
| Thrombocytopenia |
0
0%
|
1
100%
|
1
100%
|
0
0%
|
0
0%
|
1
20%
|
3
37.5%
|
1
9.1%
|
0
0%
|
1
7.1%
|
| Title | Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants |
|---|---|
| Description | An abnormal chemistry finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. |
| Time Frame | From start of study drug administration up to 30 days after the last dose of study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received any treatment of study drug. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 1 | 4 | 4 | 5 | 8 | 11 | 6 | 14 |
| Alanine aminotransferase increased |
0
0%
|
1
100%
|
0
0%
|
2
50%
|
0
0%
|
4
80%
|
2
25%
|
2
18.2%
|
2
33.3%
|
3
21.4%
|
| Aspartate aminotransferase increased |
1
100%
|
1
100%
|
1
100%
|
0
0%
|
1
25%
|
3
60%
|
5
62.5%
|
2
18.2%
|
4
66.7%
|
2
14.3%
|
| Blood creatinine increased |
1
100%
|
0
0%
|
1
100%
|
0
0%
|
2
50%
|
0
0%
|
1
12.5%
|
1
9.1%
|
1
16.7%
|
6
42.9%
|
| Blood lactate dehydrogenase increased |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
25%
|
0
0%
|
3
50%
|
0
0%
|
| Blood urea increased |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
20%
|
2
25%
|
0
0%
|
2
33.3%
|
0
0%
|
| Hyperglycaemia |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
20%
|
3
37.5%
|
0
0%
|
1
16.7%
|
2
14.3%
|
| Hyperphosphataemia |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
1
9.1%
|
1
16.7%
|
0
0%
|
| Hypoalbuminaemia |
0
0%
|
1
100%
|
1
100%
|
0
0%
|
3
75%
|
0
0%
|
1
12.5%
|
2
18.2%
|
1
16.7%
|
2
14.3%
|
| Hypocalcaemia |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
1
20%
|
0
0%
|
0
0%
|
1
16.7%
|
1
7.1%
|
| Hypokalaemia |
1
100%
|
1
100%
|
1
100%
|
1
25%
|
0
0%
|
2
40%
|
4
50%
|
1
9.1%
|
0
0%
|
1
7.1%
|
| Hypomagnesaemia |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
1
9.1%
|
0
0%
|
1
7.1%
|
| Hyponatraemia |
0
0%
|
0
0%
|
1
100%
|
0
0%
|
0
0%
|
0
0%
|
2
25%
|
0
0%
|
2
33.3%
|
1
7.1%
|
| Hypophosphataemia |
1
100%
|
1
100%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
4
50%
|
0
0%
|
1
16.7%
|
1
7.1%
|
| Title | Number of Participants With Abnormalities in Ophthalmologic Examination at End of Treatment That Were Not Present at Baseline |
|---|---|
| Description | Ophthalmologic examination included evaluation of retinal, corneal and lens abnormalities at baseline and end of treatment that were not present at screening. Participants who experienced abnormalitities during ophthalmologic examination recorded and reported. |
| Time Frame | Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received any treatment of study drug. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 1 | 4 | 4 | 5 | 8 | 11 | 6 | 14 |
| Number [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Change From Baseline in Normal Sinus Rhythm Findings in ECG |
|---|---|
| Description | Number of participants with abnormal ECG changes (compared with baseline) as assessed by study cardiologist |
| Time Frame | Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received any treatment of study drug. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 1 | 4 | 4 | 4 | 7 | 7 | 6 | 12 |
| Number [participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Change From Baseline to End of Treatment in Clinical Findings in Electrocardiogram (ECG) QT, QTC Interval and Ventricular Rate |
|---|---|
| Description | The 12-lead ECG data were summarized and evaluated for the following parameters: ,QT, QTC intervals and ventricular rate. Change from baseline in these parameters were reported. |
| Time Frame | Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received any treatment of study drug. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 1 | 4 | 4 | 5 | 8 | 11 | 6 | 14 |
| QT interval |
-107
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
-52.0
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
| QTC interval |
20.0
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
-26.0
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
| Ventricluar rate |
69.0
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
29.0
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
| Title | Best Overall Tumor Response |
|---|---|
| Description | Antitumor activity was assessed by best overall tumor response. |
| Time Frame | Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, "N" is number of participants analyzed for this outcome measure. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 1 | 4 | 4 | 4 | 7 | 7 | 6 | 12 |
| Composite complete response |
0
0%
|
1
100%
|
0
0%
|
1
25%
|
0
0%
|
1
20%
|
1
12.5%
|
2
18.2%
|
2
33.3%
|
3
21.4%
|
| Complete response |
0
0%
|
1
100%
|
0
0%
|
1
25%
|
0
0%
|
1
20%
|
1
12.5%
|
2
18.2%
|
2
33.3%
|
3
21.4%
|
| complete response with incomplete count recovery |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Partial response |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
20%
|
0
0%
|
1
9.1%
|
0
0%
|
2
14.3%
|
| Hematological activity |
0
0%
|
0
0%
|
0
0%
|
2
50%
|
3
75%
|
0
0%
|
3
37.5%
|
1
9.1%
|
1
16.7%
|
2
14.3%
|
| Stable disease |
0
0%
|
0
0%
|
1
100%
|
1
25%
|
1
25%
|
1
20%
|
2
25%
|
1
9.1%
|
0
0%
|
4
28.6%
|
| Progressive disease |
1
100%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
20%
|
1
12.5%
|
2
18.2%
|
3
50%
|
1
7.1%
|
| Title | Objective Response Rate (ORR) |
|---|---|
| Description | Objective response based on assessment of confirmed composite complete response (CRc) or partial response (PR) according to disease specific criteria [modified criteria for response in acute lymphoblastic leukemia (ALL)]. |
| Time Frame | Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy population included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug. Here, "N" is number of participants analyzed for this outcome measure. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 1 | 4 | 4 | 4 | 7 | 7 | 6 | 12 |
| Number [percentage of participants] |
0
0%
|
100
10000%
|
0
0%
|
25.0
625%
|
0
0%
|
50.0
1000%
|
14.3
178.8%
|
42.9
390%
|
33.3
555%
|
41.7
297.9%
|
| Title | Percentage of Participants With Relapse of Disease |
|---|---|
| Description | Relapse is defined as progressive disease (PD) following complete response (CR). Rate of relapse was only calculated for the subgroup of participants with complete response. |
| Time Frame | Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy population. Here, "N" is number of participants with CR in the respective cohort. Rate of relapse could not be estimated as none of the participants experienced CR in the 5 mcg/kg, 20 mcg/kg (Schema A) and 30 mcg/kg (schema A) cohort of the study. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 2 | 3 |
| Number [percentage of participants] |
0
0%
|
100
10000%
|
0
0%
|
0
0%
|
0
0%
|
50
1000%
|
0
0%
|
| Title | Time to Disease Response |
|---|---|
| Description | Time to disease response was measured from the start of moxetumomab pasudotox administration to the first documentation of response (CR or PR) and was assessed in participants who achieved objective response. |
| Time Frame | Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Population for Efficacy. Here, "N" is number of participants with objective disease response in the respective cohort. Time to disease response could not be estimated as none of the participants experienced OR in the 5 mcg/kg, 20 mcg/kg (schema A) and 30 mcg/kg (schema A). |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 0 | 1 | 0 | 1 | 0 | 2 | 1 | 3 | 2 | 5 |
| Median (Full Range) [months] |
0.69
|
0.49
|
0.66
|
0.49
|
0.72
|
0.62
|
0.66
|
| Title | Duration of Response (DR) |
|---|---|
| Description | Duration of response was defined as the duration from the first documentation of objective response to the first documented disease progression. |
| Time Frame | Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Population for Efficacy. Here, "N" is number of participants with objective disease response in the respective cohort. DR could not be estimated as none of the participants experienced OR in the 5 mcg/kg, 20 mcg/kg (schema A) and 30 mcg/kg (schema A). |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 0 | 1 | 0 | 1 | 0 | 2 | 1 | 3 | 2 | 5 |
| Median (Full Range) [months] |
NA
|
2.3
|
NA
|
NA
|
NA
|
NA
|
NA
|
| Title | Time to Disease Progression (TDP) |
|---|---|
| Description | Time to disease progression was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression. Number of progressions were reported here. |
| Time Frame | Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, "N" is number of participants analyzed for this outcome measure. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 1 | 4 | 4 | 4 | 7 | 7 | 6 | 12 |
| Median (Full Range) [months] |
0.2
|
NA
|
NA
|
2
|
NA
|
NA
|
1.2
|
1.5
|
0.8
|
NA
|
| Title | Progression-Free Survival (PFS) |
|---|---|
| Description | Progression-free survival was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression or death due to any cause, whichever occurs first. Number of progressions/deaths were reported here. |
| Time Frame | Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, "N" is number of participants analyzed for this outcome measure. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 1 | 4 | 4 | 4 | 7 | 7 | 6 | 12 |
| Median (Full Range) [months] |
0.2
|
3.6
|
1.7
|
1.8
|
NA
|
3.1
|
1.2
|
1.5
|
0.8
|
5.8
|
| Title | Overall Survival (OS) |
|---|---|
| Description | Overall survival was determined as the time from the start of treatment with Moxetumomab Pasudotox until death. Number of deaths were reported here. |
| Time Frame | Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, "N" is number of participants analyzed for this outcome measure. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 1 | 4 | 4 | 4 | 7 | 7 | 6 | 12 |
| Median (Full Range) [months] |
0.2
|
3.6
|
1.7
|
2.1
|
NA
|
4.6
|
9.4
|
NA
|
4.1
|
12.7
|
| Title | Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox |
|---|---|
| Description | The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox. |
| Time Frame | Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Population for efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg) | 30 Microgram Per Kilogram (mcg/kg) | 32 Microgram Per Kilogram (mcg/kg): Schema C | 40 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. |
| Measure Participants | 1 | 1 | 5 | 9 | 10 | 6 | 20 |
| Mean (Standard Deviation) [nanogram per milliliter (ng/mL)] |
NA
(NA)
|
126
(NA)
|
274
(135)
|
446
(126)
|
446
(156)
|
555
(196)
|
755
(188)
|
| Title | Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUC [0 to Infinity]) for Moxetumomab Pasudotox |
|---|---|
| Description | The AUC (0 to infinity) is the area under the plasma concentration-time curve from time zero to infinity hours. |
| Time Frame | Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg) | 30 Microgram Per Kilogram (mcg/kg) | 32 Microgram Per Kilogram (mcg/kg): Schema C | 40 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. |
| Measure Participants | 1 | 1 | 3 | 8 | 10 | 5 | 20 |
| Mean (Standard Deviation) [hour*nanogram per milliliter (h.ng/mL)] |
NA
(NA)
|
NA
(NA)
|
744
(514)
|
1060
(508)
|
844
(385)
|
1320
(554)
|
1690
(689)
|
| Title | Systemic Clearance (CL) for Moxetumomab Pasudotox |
|---|---|
| Description | The CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma area under the plasma concentration-time curve from time zone to infinite time (AUC[0-infinity]). |
| Time Frame | Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg) | 30 Microgram Per Kilogram (mcg/kg) | 32 Microgram Per Kilogram (mcg/kg): Schema C | 40 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. |
| Measure Participants | 1 | 1 | 3 | 8 | 10 | 5 | 20 |
| Mean (Standard Deviation) [milliliter per hour per kilogram] |
NA
(NA)
|
NA
(NA)
|
40.5
(32.3)
|
35.4
(18.2)
|
47.5
(28.2)
|
34.6
(13.2)
|
35.3
(14.7)
|
| Title | Terminal Phase Elimination Half Life (t1/2) for Moxetumomab Pasudotox |
|---|---|
| Description | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Time Frame | Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg) | 30 Microgram Per Kilogram (mcg/kg) | 32 Microgram Per Kilogram (mcg/kg): Schema C | 40 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. |
| Measure Participants | 1 | 1 | 3 | 8 | 10 | 5 | 20 |
| Mean (Standard Deviation) [hour (h)] |
NA
(NA)
|
NA
(NA)
|
0.906
(0.545)
|
1.32
(0.893)
|
0.997
(0.557)
|
0.880
(0.522)
|
1.38
(0.753)
|
| Title | Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody |
|---|---|
| Description | Participants tested for immunogenicity to CAT-8015 (moxetumomab pasudotox) prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. It was used as a direct surrogate for biological activity based on the mechanism of action of this drug. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit greater than (>)50 percentage (%) of the binding of CAT-8015 to CD22 using an ELISA-based method. |
| Time Frame | Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received any treatment of study drug. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 1 | 4 | 4 | 5 | 8 | 11 | 6 | 14 |
| ADA present by screening assay |
0
0%
|
0
0%
|
0
0%
|
1
25%
|
1
25%
|
1
20%
|
1
12.5%
|
1
9.1%
|
1
16.7%
|
1
7.1%
|
| Neutralizing ADA present by functional assay |
1
100%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
20%
|
1
12.5%
|
5
45.5%
|
0
0%
|
3
21.4%
|
| Title | CD22 Expression Cells in Peripheral Blood by Best Response |
|---|---|
| Description | Participants malignant cells (peripheral blood) was tested for cluster of differentiation 22 (CD22) expression by fluorescence-activated cell sorter (FACS) analysis. |
| Time Frame | Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received any treatment of study drug. Here, n = participants evaluable for specified category for each arm, respectively |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 1 | 4 | 4 | 5 | 8 | 11 | 6 | 14 |
| Composite complete response(n=0,1,0,1,0,1,0,2,2,3) |
NA
|
14519.0
|
NA
|
749.0
|
NA
|
3058.0
|
NA
|
2772.5
|
5620.0
|
4331.0
|
| Complete response (n=0,1,0,1,0,1,0,2,2,3) |
NA
|
14519.0
|
NA
|
749.0
|
NA
|
3058.0
|
NA
|
2772.5
|
5620.0
|
4331.0
|
| Partial response (n=0,0,0,0,0,1,0,1,0,2) |
NA
|
NA
|
NA
|
NA
|
NA
|
2387.0
|
NA
|
4514.0
|
NA
|
2366.0
|
| Hematological activity (n=0,0,0,2,3,0,3,1,1,2) |
NA
|
NA
|
NA
|
3533.5
|
2476.0
|
NA
|
1427.0
|
1350.0
|
2642.0
|
2223.5
|
| Stable response (n=0,0,1,1,1,1,2,1,0,4) |
NA
|
NA
|
5050.0
|
8083.0
|
2111.0
|
5587.0
|
8513.0
|
2521.0
|
NA
|
3904.0
|
| Progressive disease (n=1,0,0,0,0,1,1,2,3,1) |
13210.0
|
NA
|
NA
|
NA
|
NA
|
3705.0
|
1415.0
|
5505.5
|
1643.0
|
3102.0
|
| Title | Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS) |
|---|---|
| Description | Potential biomarkers include orthostatic blood pressure, albumin levels, weight change, edema and hypoxia were evaluated. |
| Time Frame | Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received any treatment of study drug. |
| Arm/Group Title | 5 Microgram Per Kilogram (mcg/kg) | 10 Microgram Per Kilogram (mcg/kg) | 20 Microgram Per Kilogram (mcg/kg): Schema A | 20 Microgram Per Kilogram (mcg/kg): Schema B | 30 Microgram Per Kilogram (mcg/kg): Schema A | 30 Microgram Per Kilogram (mcg/kg): Schema B | 40 Microgram Per Kilogram (mcg/kg): Schema B | 32 Microgram Per Kilogram (mcg/kg): Schema C | 50 Microgram Per Kilogram (mcg/kg): Schema B | 50 Microgram Per Kilogram (mcg/kg): Schema C |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. |
| Measure Participants | 1 | 1 | 1 | 4 | 4 | 5 | 8 | 11 | 6 | 14 |
| Hypertension; Event; Developed no later than CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hypertension; Event; Developed after CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
50%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hypertension; Event; No CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
18.2%
|
1
16.7%
|
5
35.7%
|
| Hypertension; No Event; No CLS |
1
100%
|
1
100%
|
1
100%
|
4
100%
|
2
50%
|
4
80%
|
8
100%
|
9
81.8%
|
5
83.3%
|
8
57.1%
|
| Hypertension; No Event; CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
1
7.1%
|
| Weight change; Event; Developed no later than CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Weight change; Event; Developed after CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Weight change; Event; No CLS |
0
0%
|
0
0%
|
0
0%
|
2
50%
|
0
0%
|
1
20%
|
0
0%
|
3
27.3%
|
0
0%
|
3
21.4%
|
| Weight change; No Event; No CLS |
1
100%
|
1
100%
|
1
100%
|
2
50%
|
2
50%
|
3
60%
|
8
100%
|
8
72.7%
|
6
100%
|
10
71.4%
|
| Weight change; No Event; CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
1
7.1%
|
| Change in Albumin; Event; Developed no later CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Change in Albumin; Event; Developed after CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Change in Albumin; Event; No CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
1
7.1%
|
| Change in Albumin; No Event; No CLS |
1
100%
|
1
100%
|
1
100%
|
4
100%
|
2
50%
|
3
60%
|
8
100%
|
11
100%
|
6
100%
|
13
92.9%
|
| Change in Albumin; No Event; CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
50%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
1
7.1%
|
| Edema; Event; Developed no later than CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Edema; Event; Developed after CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Edema; Event; No CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Edema; No Event; No CLS |
1
100%
|
1
100%
|
1
100%
|
4
100%
|
2
50%
|
4
80%
|
8
100%
|
11
100%
|
6
100%
|
13
92.9%
|
| Edema; No Event; CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
50%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
7.1%
|
| Hypoxia; Event; Developed no later than CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hypoxia; Event; Developed after CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hypoxia; Event; No CLS |
1
100%
|
0
0%
|
1
100%
|
1
25%
|
0
0%
|
0
0%
|
1
12.5%
|
2
18.2%
|
2
33.3%
|
1
7.1%
|
| Hypoxia; No Event; No CLS |
0
0%
|
1
100%
|
0
0%
|
3
75%
|
2
50%
|
4
80%
|
7
87.5%
|
9
81.8%
|
4
66.7%
|
12
85.7%
|
| Hypoxia; No Event; CLS |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
7.1%
|
Adverse Events
| Time Frame | From start of study drug administration up to 30 days after the last dose of study drug | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||||
| Arm/Group Title | 5 UG/KG SCHEMA A | 10 UG/KG SCHEMA A | 20 UG/KG SCHEMA A | 20 UG/KG SCHEMA B | 30 UG/KG SCHEMA A | 30 UG/KG SCHEMA B | 40 UG/KG SCHEMA B | 32 UG/KG SCHEMA C | 50 UG/KG SCHEMA B | 50 UG/KG SCHEMA C | ||||||||||
| Arm/Group Description | Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle. | Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle. | ||||||||||
All Cause Mortality |
||||||||||||||||||||
| 5 UG/KG SCHEMA A | 10 UG/KG SCHEMA A | 20 UG/KG SCHEMA A | 20 UG/KG SCHEMA B | 30 UG/KG SCHEMA A | 30 UG/KG SCHEMA B | 40 UG/KG SCHEMA B | 32 UG/KG SCHEMA C | 50 UG/KG SCHEMA B | 50 UG/KG SCHEMA C | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||
Serious Adverse Events |
||||||||||||||||||||
| 5 UG/KG SCHEMA A | 10 UG/KG SCHEMA A | 20 UG/KG SCHEMA A | 20 UG/KG SCHEMA B | 30 UG/KG SCHEMA A | 30 UG/KG SCHEMA B | 40 UG/KG SCHEMA B | 32 UG/KG SCHEMA C | 50 UG/KG SCHEMA B | 50 UG/KG SCHEMA C | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) | 4/4 (100%) | 3/4 (75%) | 2/5 (40%) | 5/8 (62.5%) | 7/11 (63.6%) | 4/6 (66.7%) | 9/14 (64.3%) | ||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||
| Febrile neutropenia | 0/1 (0%) | 0 | 1/1 (100%) | 2 | 1/1 (100%) | 2 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 1/5 (20%) | 2 | 2/8 (25%) | 3 | 1/11 (9.1%) | 2 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Haemolytic uraemic syndrome | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 3/14 (21.4%) | 3 |
| Thrombocytopenia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Cardiac disorders | ||||||||||||||||||||
| Cardiac arrest | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Eye disorders | ||||||||||||||||||||
| Choroidal detachment | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||||
| Upper gastrointestinal haemorrhage | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Colitis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| General disorders | ||||||||||||||||||||
| Brain death | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
| Multi-organ failure | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 |
| Pyrexia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 2/8 (25%) | 2 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Disease progression | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||||||||||
| Hepatobiliary disease | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Venoocclusive liver disease | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
| Infections and infestations | ||||||||||||||||||||
| Bacteraemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Bacterial infection | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 2 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Geotrichum infection | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
| Herpes zoster | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
| Opportunistic infection | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Pneumonia fungal | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Sepsis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 |
| Staphylococcal sepsis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Neutropenic infection | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 2/14 (14.3%) | 2 |
| Septic shock | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 2 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Systemic mycosis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Tooth infection | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Investigations | ||||||||||||||||||||
| Blood creatinine increased | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 2/14 (14.3%) | 2 |
| Aspartate aminotransferase increased | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Troponin | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||||||
| Hypercalcaemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/8 (12.5%) | 2 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||
| Acute lymphocytic leukaemia recurrent | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
| Leukaemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||||
| Central nervous system haemorrhage | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
| Coma | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Seizure | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||||||||
| Haemoglobinuria | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Proteinuria | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Renal failure | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 2/14 (14.3%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
| Hypoxia | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 |
| Lung infiltration | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 |
| Pleural effusion | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 2/4 (50%) | 3 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Pneumonitis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 3 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Pulmonary haemorrhage | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Acute respiratory distress syndrome | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
| Dyspnoea | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Epistaxis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Respiratory distress | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Vascular disorders | ||||||||||||||||||||
| Capillary leak syndrome | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 2/4 (50%) | 2 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
| Haemorrhage | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Hypotension | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Thrombosis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 |
| Venoocclusive disease | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||
| 5 UG/KG SCHEMA A | 10 UG/KG SCHEMA A | 20 UG/KG SCHEMA A | 20 UG/KG SCHEMA B | 30 UG/KG SCHEMA A | 30 UG/KG SCHEMA B | 40 UG/KG SCHEMA B | 32 UG/KG SCHEMA C | 50 UG/KG SCHEMA B | 50 UG/KG SCHEMA C | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) | 4/4 (100%) | 4/4 (100%) | 5/5 (100%) | 8/8 (100%) | 11/11 (100%) | 6/6 (100%) | 14/14 (100%) | ||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||
| Anaemia | 0/1 (0%) | 0 | 1/1 (100%) | 19 | 1/1 (100%) | 12 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 2/8 (25%) | 12 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 3/14 (21.4%) | 17 |
| Febrile neutropenia | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 2/4 (50%) | 2 | 0/5 (0%) | 0 | 2/8 (25%) | 2 | 4/11 (36.4%) | 4 | 0/6 (0%) | 0 | 2/14 (14.3%) | 2 |
| Leukopenia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 3 | 3/8 (37.5%) | 7 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 12 |
| Lymphopenia | 0/1 (0%) | 0 | 1/1 (100%) | 13 | 1/1 (100%) | 4 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 4 | 3/8 (37.5%) | 7 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 10 |
| Neutropenia | 0/1 (0%) | 0 | 1/1 (100%) | 7 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 7 |
| Thrombocytopenia | 0/1 (0%) | 0 | 1/1 (100%) | 38 | 1/1 (100%) | 8 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 12 | 3/8 (37.5%) | 24 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 15 |
| Cardiac disorders | ||||||||||||||||||||
| Sinus tachycardia | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 2 |
| Tachycardia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 2/4 (50%) | 3 | 3/4 (75%) | 3 | 3/5 (60%) | 4 | 2/8 (25%) | 2 | 2/11 (18.2%) | 2 | 0/6 (0%) | 0 | 3/14 (21.4%) | 4 |
| Bradycardia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 1/5 (20%) | 1 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
| Pericardial effusion | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
| Eye disorders | ||||||||||||||||||||
| Vision blurred | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 3/11 (27.3%) | 3 | 0/6 (0%) | 0 | 3/14 (21.4%) | 3 |
| Gastrointestinal disorders | ||||||||||||||||||||
| Abdominal pain | 0/1 (0%) | 0 | 1/1 (100%) | 4 | 1/1 (100%) | 1 | 1/4 (25%) | 1 | 1/4 (25%) | 1 | 3/5 (60%) | 3 | 2/8 (25%) | 2 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Colitis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 |
| Constipation | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 3/14 (21.4%) | 3 |
| Diarrhoea | 0/1 (0%) | 0 | 1/1 (100%) | 2 | 1/1 (100%) | 3 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 3/8 (37.5%) | 5 | 4/11 (36.4%) | 4 | 1/6 (16.7%) | 1 | 2/14 (14.3%) | 2 |
| Nausea | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 2/4 (50%) | 7 | 0/5 (0%) | 0 | 4/8 (50%) | 7 | 2/11 (18.2%) | 2 | 0/6 (0%) | 0 | 5/14 (35.7%) | 6 |
| Stomatitis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 4 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 2/14 (14.3%) | 2 |
| Vomiting | 0/1 (0%) | 0 | 1/1 (100%) | 4 | 1/1 (100%) | 3 | 1/4 (25%) | 1 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 2/8 (25%) | 5 | 2/11 (18.2%) | 2 | 0/6 (0%) | 0 | 3/14 (21.4%) | 4 |
| Dyspepsia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 2 | 1/8 (12.5%) | 2 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 2/14 (14.3%) | 2 |
| Oral pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 2/14 (14.3%) | 3 |
| General disorders | ||||||||||||||||||||
| Catheter site pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 3/11 (27.3%) | 3 | 0/6 (0%) | 0 | 2/14 (14.3%) | 2 |
| Fatigue | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 3/5 (60%) | 3 | 0/8 (0%) | 0 | 4/11 (36.4%) | 4 | 1/6 (16.7%) | 2 | 5/14 (35.7%) | 5 |
| Oedema | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 1/4 (25%) | 1 | 2/5 (40%) | 3 | 1/8 (12.5%) | 1 | 2/11 (18.2%) | 2 | 1/6 (16.7%) | 2 | 4/14 (28.6%) | 7 |
| Oedema peripheral | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 4/11 (36.4%) | 5 | 1/6 (16.7%) | 1 | 4/14 (28.6%) | 6 |
| Pyrexia | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 3/4 (75%) | 3 | 2/5 (40%) | 2 | 0/8 (0%) | 0 | 2/11 (18.2%) | 3 | 2/6 (33.3%) | 5 | 7/14 (50%) | 15 |
| Hepatobiliary disorders | ||||||||||||||||||||
| Hyperbilirubinaemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 2 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 6 |
| Infections and infestations | ||||||||||||||||||||
| Sinusitis | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 2/14 (14.3%) | 2 |
| Investigations | ||||||||||||||||||||
| Activated partial thromboplastin time prolonged | 0/1 (0%) | 0 | 1/1 (100%) | 3 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 2/8 (25%) | 2 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Alanine aminotransferase increased | 0/1 (0%) | 0 | 1/1 (100%) | 2 | 0/1 (0%) | 0 | 2/4 (50%) | 2 | 0/4 (0%) | 0 | 4/5 (80%) | 8 | 2/8 (25%) | 10 | 2/11 (18.2%) | 3 | 2/6 (33.3%) | 6 | 3/14 (21.4%) | 8 |
| Aspartate aminotransferase increased | 1/1 (100%) | 1 | 1/1 (100%) | 2 | 1/1 (100%) | 1 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 3/5 (60%) | 5 | 5/8 (62.5%) | 10 | 2/11 (18.2%) | 2 | 4/6 (66.7%) | 7 | 2/14 (14.3%) | 5 |
| Blood lactate dehydrogenase increased | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 2/8 (25%) | 2 | 0/11 (0%) | 0 | 3/6 (50%) | 5 | 0/14 (0%) | 0 |
| Blood urea increased | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 2/8 (25%) | 4 | 0/11 (0%) | 0 | 2/6 (33.3%) | 3 | 0/14 (0%) | 0 |
| Electrocardiogram qt prolonged | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 | 1/14 (7.1%) | 1 |
| Neutrophil count decreased | 0/1 (0%) | 0 | 1/1 (100%) | 2 | 1/1 (100%) | 1 | 1/4 (25%) | 3 | 3/4 (75%) | 20 | 2/5 (40%) | 11 | 2/8 (25%) | 3 | 3/11 (27.3%) | 5 | 1/6 (16.7%) | 3 | 8/14 (57.1%) | 17 |
| Platelet count decreased | 0/1 (0%) | 0 | 1/1 (100%) | 2 | 0/1 (0%) | 0 | 1/4 (25%) | 2 | 4/4 (100%) | 23 | 4/5 (80%) | 33 | 3/8 (37.5%) | 25 | 6/11 (54.5%) | 39 | 4/6 (66.7%) | 17 | 7/14 (50%) | 37 |
| Weight increased | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 4/4 (100%) | 8 | 2/4 (50%) | 6 | 2/5 (40%) | 4 | 0/8 (0%) | 0 | 7/11 (63.6%) | 15 | 3/6 (50%) | 4 | 4/14 (28.6%) | 15 |
| White blood cell count decreased | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 3/4 (75%) | 16 | 2/4 (50%) | 10 | 3/5 (60%) | 5 | 1/8 (12.5%) | 8 | 4/11 (36.4%) | 8 | 2/6 (33.3%) | 11 | 8/14 (57.1%) | 43 |
| Blood creatinine increased | 1/1 (100%) | 2 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/4 (0%) | 0 | 2/4 (50%) | 2 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 3 | 6/14 (42.9%) | 13 |
| Haemoglobin decreased | 1/1 (100%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 3/4 (75%) | 8 | 4/4 (100%) | 11 | 3/5 (60%) | 7 | 2/8 (25%) | 10 | 4/11 (36.4%) | 9 | 2/6 (33.3%) | 12 | 8/14 (57.1%) | 38 |
| Metabolism and nutrition disorders | ||||||||||||||||||||
| Decreased appetite | 0/1 (0%) | 0 | 1/1 (100%) | 2 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 2/8 (25%) | 2 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Hyperglycaemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 3 | 3/8 (37.5%) | 5 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 | 2/14 (14.3%) | 13 |
| Hyperphosphataemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/8 (12.5%) | 3 | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 |
| Hypoalbuminaemia | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 1/1 (100%) | 4 | 0/4 (0%) | 0 | 3/4 (75%) | 7 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 2/11 (18.2%) | 2 | 1/6 (16.7%) | 2 | 2/14 (14.3%) | 4 |
| Hypocalcaemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 1/5 (20%) | 2 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 | 1/14 (7.1%) | 6 |
| Hypokalaemia | 1/1 (100%) | 1 | 1/1 (100%) | 3 | 1/1 (100%) | 2 | 1/4 (25%) | 3 | 0/4 (0%) | 0 | 2/5 (40%) | 3 | 4/8 (50%) | 5 | 1/11 (9.1%) | 3 | 0/6 (0%) | 0 | 1/14 (7.1%) | 4 |
| Hypomagnesaemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 1/14 (7.1%) | 5 |
| Hyponatraemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 2/8 (25%) | 3 | 0/11 (0%) | 0 | 2/6 (33.3%) | 2 | 1/14 (7.1%) | 1 |
| Hypophosphataemia | 1/1 (100%) | 1 | 1/1 (100%) | 2 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 4/8 (50%) | 4 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 | 1/14 (7.1%) | 8 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||
| Bone pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 3/8 (37.5%) | 3 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Musculoskeletal pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 3/11 (27.3%) | 3 | 0/6 (0%) | 0 | 3/14 (21.4%) | 3 |
| Myalgia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 3/11 (27.3%) | 3 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
| Pain in jaw | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/8 (12.5%) | 2 | 2/11 (18.2%) | 2 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
| Back pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 2/8 (25%) | 3 | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 1 | 2/14 (14.3%) | 2 |
| Musculoskeletal chest pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Pain in extremity | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 1/1 (100%) | 1 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 | 2/6 (33.3%) | 2 | 1/14 (7.1%) | 1 |
| Nervous system disorders | ||||||||||||||||||||
| Headache | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 1/4 (25%) | 2 | 2/5 (40%) | 5 | 1/8 (12.5%) | 3 | 4/11 (36.4%) | 6 | 2/6 (33.3%) | 2 | 7/14 (50%) | 10 |
| Psychiatric disorders | ||||||||||||||||||||
| Anxiety | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 1 | 2/14 (14.3%) | 2 |
| Insomnia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 1/8 (12.5%) | 1 | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||||||||
| Haemoglobinuria | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 2/4 (50%) | 3 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Proteinuria | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 2/11 (18.2%) | 3 | 1/6 (16.7%) | 1 | 1/14 (7.1%) | 4 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
| Cough | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 2/4 (50%) | 2 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Dyspnoea | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 4/14 (28.6%) | 7 |
| Oropharyngeal pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 | 2/14 (14.3%) | 2 |
| Pleural effusion | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 2/14 (14.3%) | 3 |
| Epistaxis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 1/5 (20%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 | 2/14 (14.3%) | 4 |
| Hypoxia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 2/4 (50%) | 2 | 1/5 (20%) | 3 | 0/8 (0%) | 0 | 2/11 (18.2%) | 2 | 1/6 (16.7%) | 1 | 1/14 (7.1%) | 2 |
| Pulmonary oedema | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 2/14 (14.3%) | 2 |
| Tachypnoea | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 1/4 (25%) | 2 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||
| Dry skin | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/5 (20%) | 1 | 1/8 (12.5%) | 1 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
| Petechiae | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 1/4 (25%) | 1 | 0/5 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/6 (0%) | 0 | 2/14 (14.3%) | 2 |
| Pruritus | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 1/5 (20%) | 1 | 1/8 (12.5%) | 1 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 | 2/14 (14.3%) | 2 |
| Rash | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 2 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 2/5 (40%) | 4 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 | 1/6 (16.7%) | 2 | 1/14 (7.1%) | 1 |
| Vascular disorders | ||||||||||||||||||||
| Hypertension | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 2/4 (50%) | 2 | 0/5 (0%) | 0 | 1/8 (12.5%) | 1 | 3/11 (27.3%) | 3 | 1/6 (16.7%) | 1 | 5/14 (35.7%) | 9 |
| Hypotension | 0/1 (0%) | 0 | 1/1 (100%) | 3 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 2/5 (40%) | 3 | 2/8 (25%) | 2 | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 1 | 1/14 (7.1%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
| Name/Title | Mark Lanasa, MD Associate Director, Clinical Development, Oncology |
|---|---|
| Organization | MedImmune, LLC |
| Phone | 301-398-0000 |
| information.center@AstraZeneca.com |
Responsible Party:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00659425
Other Study ID Numbers:
- CAT-8015-1004
First Posted:
Apr 16, 2008
Last Update Posted:
Oct 2, 2017
Last Verified:
Aug 1, 2017