Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma
Sponsor
Millennium Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00807495
Collaborator
(none)
48
1
1
48.1
1
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the anti-tumor activity of alisertib (MLN8237) in participants with relapsed or refractory non-hodgkin's lymphoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have relapsed or refractory non-Hodgkin's lymphoma (NHL). The study looked at anti-tumor activity in participants who received alisertib.
The study enrolled 48 patients. Participants were categorized as per disease subtypes into five subtypes: Large B-Cell lymphoma, mantle cell lymphoma, transformed follicular lymphoma, Burkitts lymphoma and aggressive T-Cell lymphoma (Note: There were no participants enrolled with Precursor B-lymphoblastic Leukemia/Lymphoma). Participants received:
• Alisertib 50 mg BID on Days 1 to 7
All participants took alisertib capsules approximately every 12 hours each day for 7 days followed by a 14-day rest period in a 21-days cycle. MLN8237 was supplied in capsules of 5 or 25 mg strength.
This multi-center trial was conducted in United States. The overall time to participate in this study was until there is evidence of disease progression or unacceptable treatment-related toxicity. If the participant would derive benefit from continued alisertib treatment beyond 24 months, the Sponsor was consulted for approval of further treatment. Participants made multiple visits to the clinic, with imaging assessments every 12 weeks. Participants discontinuing treatment prior to disease progression continue with clinic visits, chemistry and hematology lab testing, and tumor assessments every 12 weeks up to 12 months after last dose of study drug for follow-up assessments.
Study Design
Study Type:
Interventional
Actual Enrollment
:
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Trial of MLN8237, an Oral Aurora A Kinase Inhibitor, in Adult Patients With Aggressive Non-Hodgkin's Lymphoma
Actual Study Start Date
:
Feb 10, 2009
Actual Primary Completion Date
:
Jan 4, 2011
Actual Study Completion Date
:
Feb 13, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Alisertib 50 mg Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months or longer with Sponsor approval). |
Drug: Alisertib
Alisertib capsules
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Best Overall Response Rate Based on Investigator's Assessment (Applying the IWG 2007 Response Criteria) [Baseline and every 2 cycles up to Month 12 (approximately 16 cycles), from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months from last dose (Up to 4 years)]
Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites (as specified in the Cheson 2007, IWG response criteria).
Secondary Outcome Measures
- Time to Progression (TTP) [Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)]
Time to progression (TTP) is defined as the time in days from the date of first study drug administration to the date of first documentation of Progressive Disease (PD) according to IWG criteria (Cheson 2007). PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.
- Progression Free Survival (PFS) [Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)]
PFS is defined as the time in days from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death.
- Duration of Response (DOR) [Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)]
DOR is defined as the time from the date of first documentation of a CR, or partial response (PR) to the date of first documentation of PD according to IWG criteria. CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir, as described in the IWG response criteria (Cheson 2007).
- Number of Participants With Treatment-Emergent Adverse Events [First dose of study drug to 30 days after last dose (Up to 25 months)]
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and includes all-causality (ie, treatment-related and not treatment-related as assessed by the investigator).
- Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events [First dose of study drug to 30 days after last dose (Up to 25 months)]
Vital signs (blood pressure, heart rate, and oral temperature) measurements were obtained throughout the study. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
- Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events [First dose of study drug to 30 days after last dose (Up to 25 months)]
Abnormal laboratory values for chemistry or hematology tests that were assessed by the investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V4). A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Each participant must meet all of the following inclusion criteria to be enrolled in the study:
- Participant must have histological or cytological diagnosis of a hematological malignancy of the following types that has relapsed or was refractory to prior therapy:
-
Diffuse large B-cell lymphoma
-
Mantle cell lymphoma
-
Burkitt's lymphoma
-
Precursor B-lymphoblastic leukemia/lymphoma
-
T-cell lymphoma, excluding primary cutaneous T-cell lymphoma
-
Transformed follicular lymphoma with ≥ 50% diffuse large cell component.
-
Male or female participants 18 years or older.
-
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
-
Measurable disease.
Exclusion criteria include the following:
-
Pregnant or lactating females.
-
Known human immunodeficiency virus (HIV) positive or AIDS-related illness.
-
Any serious medical or psychiatric illness that could interfere with the completion of treatment.
-
Total bilirubin ≥ 1.5 × the upper limit of normal (ULN).
-
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2.5 × the ULN. AST, ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to their underlying hematological disorder.
-
Absolute neutrophil count (ANC) < 1,250/mm^3.
-
Platelet count < 75,000/mm^3.
-
Calculated creatinine clearance < 30 mL/minute.
-
Autologous stem cell transplant less than 6 months prior to enrollment.
-
Participants who have undergone allogeneic stem cell or organ transplantation.
-
Systemic antineoplastic therapy including glucocorticoids (> 15 mg prednisone/day or equivalent), or treatment with an investigational agent within 14 days preceding the first dose of study drug treatment.
-
Participants who have received treatment with nitrosoureas, mitomycin C, rituximab, alemtuzumab, or other unconjugated antibody treatment, within 12 weeks prior to first dose.
-
Participants who have received treatment with radioimmunoconjugates or within 12 weeks prior to first dose.
-
Participants who have received radiotherapy within 21 days prior to first dose.
-
Myocardial infarction within 6 months of enrollment or current history of New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
-
Major surgery within 14 days prior to the first dose.
-
Infection requiring systemic antibiotic therapy within 14 days prior to the first dose or other serious infection.
-
Clinically uncontrolled central nervous system (CNS) involvement.
-
Inability to swallow capsules.
-
History of uncontrolled sleep apnoea syndrome and other conditions that could result in excessive daytime sleepiness (eg, Chronic obstructive pulmonary disease - COPD).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hematology Oncology Associates, Virtua Memorial Hospital Burlington County | Mount Holly | New Jersey | United States | 08060 |
Sponsors and Collaborators
- Millennium Pharmaceuticals, Inc.
Investigators
- Study Director: Medical Director Clinical Science, Millennium Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00807495
Other Study ID Numbers:
- C14004
- U1111-1187-1268
First Posted:
Dec 12, 2008
Last Update Posted:
Mar 27, 2018
Last Verified:
Feb 1, 2018
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Millennium Pharmaceuticals, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants took part in the study at 12 investigative sites in the United States from 10 February 2009 to last participant off study 13 February 2013, with a data cut-off on 04 January 2011 to report the primary endpoint. |
|---|---|
| Pre-assignment Detail | Participants with a diagnosis of Aggressive Non-Hodgkin's Lymphoma received 50 mg alisertib twice daily for 7 days in 21 day cycles. Results are categorized as disease sub-types: Diffuse Large B-cell lymphoma (DLBL), Mantle Cell lymphoma (MCL), Transformed Follicular lymphoma (TFL), Burkitts lymphoma (BL) and Aggressive T-Cell lymphoma (ATL). |
| Arm/Group Title | Alisertib 50 mg BID Starting Dose (DLBL) | Alisertib 50 mg BID Starting Dose (MCL) | Alisertib 50 mg BID Starting Dose (TFL) | Alisertib 50 mg BID Starting Dose (BL) | Alisertib 50 mg BID Starting Dose (ATL) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). |
| Period Title: Overall Study | |||||
| STARTED | 22 | 13 | 5 | 1 | 7 |
| COMPLETED | 14 | 7 | 1 | 0 | 2 |
| NOT COMPLETED | 8 | 6 | 4 | 1 | 5 |
Baseline Characteristics
| Arm/Group Title | Alisertib 50 mg BID Starting Dose (DLBL) | Alisertib 50 mg BID Starting Dose (MCL) | Alisertib 50 mg BID Starting Dose (TFL) | Alisertib 50 mg BID Starting Dose (BL) | Alisertib 50 mg BID Starting Dose (ATL) | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Total of all reporting groups |
| Overall Participants | 22 | 13 | 5 | 1 | 7 | 48 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
66.8
(11.11)
|
67.2
(6.71)
|
65.2
(9.96)
|
76.0
(NA)
|
54.4
(16.90)
|
65.1
(11.56)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
9
40.9%
|
1
7.7%
|
3
60%
|
0
0%
|
0
0%
|
13
27.1%
|
| Male |
13
59.1%
|
12
92.3%
|
2
40%
|
1
100%
|
7
100%
|
35
72.9%
|
| Race/Ethnicity, Customized (participants) [Number] | ||||||
| White |
21
95.5%
|
13
100%
|
5
100%
|
1
100%
|
7
100%
|
47
97.9%
|
| Other |
1
4.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.1%
|
| Race/Ethnicity, Customized (participants) [Number] | ||||||
| Hispanic or Latino |
1
4.5%
|
0
0%
|
1
20%
|
0
0%
|
1
14.3%
|
3
6.3%
|
| Not Hispanic or Latino |
21
95.5%
|
13
100%
|
4
80%
|
1
100%
|
6
85.7%
|
45
93.8%
|
| Weight (kg) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [kg] |
88.85
(27.022)
|
96.18
(25.139)
|
89.06
(29.724)
|
72.58
(NA)
|
84.45
(14.494)
|
89.88
(24.737)
|
Outcome Measures
| Title | Best Overall Response Rate Based on Investigator's Assessment (Applying the IWG 2007 Response Criteria) |
|---|---|
| Description | Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites (as specified in the Cheson 2007, IWG response criteria). |
| Time Frame | Baseline and every 2 cycles up to Month 12 (approximately 16 cycles), from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months from last dose (Up to 4 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population was defined as all participants who received any amount of alisertib. Efficacy analysis for the response-evaluable population is a subset of the safety population, with participants having a minimum of baseline imaging and one on-study imaging. |
| Arm/Group Title | Alisertib 50 mg BID Starting Dose (DLBL) | Alisertib 50 mg BID Starting Dose (MCL) | Alisertib 50 mg BID Starting Dose (TFL) | Alisertib 50 mg BID Starting Dose (BL) | Alisertib 50 mg BID Starting Dose (ATL) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). |
| Measure Participants | 16 | 13 | 5 | 1 | 6 |
| Number [percentage of participants] |
25
113.6%
|
23
176.9%
|
40
800%
|
100
10000%
|
50
714.3%
|
| Title | Time to Progression (TTP) |
|---|---|
| Description | Time to progression (TTP) is defined as the time in days from the date of first study drug administration to the date of first documentation of Progressive Disease (PD) according to IWG criteria (Cheson 2007). PD is defined as any new lesion or increase by >50% of previously involved sites from nadir. |
| Time Frame | Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. Here number of participants analyzed were participants with PD. TTP was censored at the last response assessment that was SD or better. |
| Arm/Group Title | Alisertib 50 mg BID Starting Dose (DLBL) | Alisertib 50 mg BID Starting Dose (MCL) | Alisertib 50 mg BID Starting Dose (TFL) | Alisertib 50 mg BID Starting Dose (BL) | Alisertib 50 mg BID Starting Dose (ATL) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). |
| Measure Participants | 16 | 13 | 5 | 1 | 6 |
| Median (95% Confidence Interval) [days] |
84.0
|
139.0
|
NA
|
NA
|
237.0
|
| Title | Progression Free Survival (PFS) |
|---|---|
| Description | PFS is defined as the time in days from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death. |
| Time Frame | Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. For a participant who had not progressed and had not died, PFS was censored at the last response assessment that was SD or better. |
| Arm/Group Title | Alisertib 50 mg BID Starting Dose (DLBL) | Alisertib 50 mg BID Starting Dose (MCL) | Alisertib 50 mg BID Starting Dose (TFL) | Alisertib 50 mg BID Starting Dose (BL) | Alisertib 50 mg BID Starting Dose (ATL) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). |
| Measure Participants | 16 | 13 | 5 | 1 | 6 |
| Median (95% Confidence Interval) [days] |
84.0
|
139.0
|
NA
|
NA
|
237.0
|
| Title | Duration of Response (DOR) |
|---|---|
| Description | DOR is defined as the time from the date of first documentation of a CR, or partial response (PR) to the date of first documentation of PD according to IWG criteria. CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir, as described in the IWG response criteria (Cheson 2007). |
| Time Frame | Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. All responders were evaluated in this outcome measure. Participants who had not progressed, DOR was censored at last response assessment that was SD or better. |
| Arm/Group Title | Alisertib 50 mg BID Starting Dose (DLBL) | Alisertib 50 mg BID Starting Dose (MCL) | Alisertib 50 mg BID Starting Dose (TFL) | Alisertib 50 mg BID Starting Dose (BL) | Alisertib 50 mg BID Starting Dose (ATL) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). |
| Measure Participants | 4 | 3 | 2 | 1 | 3 |
| Median (95% Confidence Interval) [days] |
454.0
|
646.0
|
NA
|
NA
|
596.0
|
| Title | Number of Participants With Treatment-Emergent Adverse Events |
|---|---|
| Description | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and includes all-causality (ie, treatment-related and not treatment-related as assessed by the investigator). |
| Time Frame | First dose of study drug to 30 days after last dose (Up to 25 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population was defined as all participants who received any amount of alisertib. |
| Arm/Group Title | Alisertib 50 mg BID Starting Dose (DLBL) | Alisertib 50 mg BID Starting Dose (MCL) | Alisertib 50 mg BID Starting Dose (TFL) | Alisertib 50 mg BID Starting Dose (BL) | Alisertib 50 mg BID Starting Dose (ATL) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). |
| Measure Participants | 22 | 13 | 5 | 1 | 7 |
| Number [participants] |
22
100%
|
13
100%
|
5
100%
|
1
100%
|
7
100%
|
| Title | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events |
|---|---|
| Description | Vital signs (blood pressure, heart rate, and oral temperature) measurements were obtained throughout the study. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. |
| Time Frame | First dose of study drug to 30 days after last dose (Up to 25 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population was defined as all participants who received any amount of alisertib. |
| Arm/Group Title | Alisertib 50 mg BID Starting Dose (DLBL) | Alisertib 50 mg BID Starting Dose (MCL) | Alisertib 50 mg BID Starting Dose (TFL) | Alisertib 50 mg BID Starting Dose (BL) | Alisertib 50 mg BID Starting Dose (ATL) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). |
| Measure Participants | 22 | 13 | 5 | 1 | 7 |
| Pyrexia |
7
31.8%
|
0
0%
|
0
0%
|
0
0%
|
2
28.6%
|
| Hypotension |
6
27.3%
|
1
7.7%
|
1
20%
|
0
0%
|
1
14.3%
|
| Weight decreased |
2
9.1%
|
1
7.7%
|
0
0%
|
0
0%
|
1
14.3%
|
| Tachycardia |
1
4.5%
|
0
0%
|
0
0%
|
0
0%
|
2
28.6%
|
| Hypertension |
1
4.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Bradycardia |
1
4.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Cardiac flutter |
1
4.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events |
|---|---|
| Description | Abnormal laboratory values for chemistry or hematology tests that were assessed by the investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V4). A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. |
| Time Frame | First dose of study drug to 30 days after last dose (Up to 25 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population was defined as all participants who received any amount of alisertib. |
| Arm/Group Title | Alisertib 50 mg BID Starting Dose (DLBL) | Alisertib 50 mg BID Starting Dose (MCL) | Alisertib 50 mg BID Starting Dose (TFL) | Alisertib 50 mg BID Starting Dose (BL) | Alisertib 50 mg BID Starting Dose (ATL) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). |
| Measure Participants | 22 | 13 | 5 | 1 | 7 |
| Thrombocytopenia |
11
50%
|
5
38.5%
|
3
60%
|
1
100%
|
5
71.4%
|
| Alanine aminotransferase increased |
6
27.3%
|
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
| Aspartate aminotransferase increased |
6
27.3%
|
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
| Blood alkaline phosphatase increased |
6
27.3%
|
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
| Hypokalaemia |
3
13.6%
|
0
0%
|
1
20%
|
0
0%
|
1
14.3%
|
| Blood lactate dehydrogenase increased |
3
13.6%
|
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
| Blood creatinine increased |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
28.6%
|
| Blood potassium decreased |
1
4.5%
|
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
| Lymphopenia |
1
4.5%
|
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
| Blood urea increased |
1
4.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hypercalcaemia |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
| Hypernatraemia |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
| Hypophosphataemia |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
| Mean cell volume increased |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
| Urine colour abnormal |
0
0%
|
1
7.7%
|
0
0%
|
0
0%
|
0
0%
|
| Neutropenia |
13
59.1%
|
9
69.2%
|
3
60%
|
1
100%
|
4
57.1%
|
Adverse Events
| Time Frame | First dose of study drug to 30 days after last dose (Up to 25 Months) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment. | |||||||||
| Arm/Group Title | Alisertib 50 mg BID Starting Dose (DLBL) | Alisertib 50 mg BID Starting Dose (MCL) | Alisertib 50 mg BID Starting Dose (TFL) | Alisertib 50 mg BID Starting Dose (BL) | Alisertib 50 mg BID Starting Dose (ATL) | |||||
| Arm/Group Description | Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). | |||||
All Cause Mortality |
||||||||||
| Alisertib 50 mg BID Starting Dose (DLBL) | Alisertib 50 mg BID Starting Dose (MCL) | Alisertib 50 mg BID Starting Dose (TFL) | Alisertib 50 mg BID Starting Dose (BL) | Alisertib 50 mg BID Starting Dose (ATL) | ||||||
| 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) | |||||
Serious Adverse Events |
||||||||||
| Alisertib 50 mg BID Starting Dose (DLBL) | Alisertib 50 mg BID Starting Dose (MCL) | Alisertib 50 mg BID Starting Dose (TFL) | Alisertib 50 mg BID Starting Dose (BL) | Alisertib 50 mg BID Starting Dose (ATL) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/22 (72.7%) | 4/13 (30.8%) | 5/5 (100%) | 0/1 (0%) | 4/7 (57.1%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Febrile Neutropenia | 6/22 (27.3%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Neutropenia | 3/22 (13.6%) | 2/13 (15.4%) | 1/5 (20%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Anaemia | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Pancytopenia | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Haemolytic anaemia | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Thrombocytopenia | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Cardiac disorders | ||||||||||
| Cardiac failure | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Acute myocardial infarction | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Atrial fibrillation | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Stomatitis | 4/22 (18.2%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Colitis ischaemic | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Abdominal pain upper | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Constipation | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Dysphagia | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Nausea | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| General disorders | ||||||||||
| Asthenia | 1/22 (4.5%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Pyrexia | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Multi-organ failure | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Mucosal haemorrhage | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Death | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Infections and infestations | ||||||||||
| Pneumonia | 3/22 (13.6%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Urinary tract infection | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Cellulitis | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Osteomyelitis | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Oropharyngeal candidiasis | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Escherichia bacteraemia | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Sepsis | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Oral candidiasis | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Investigations | ||||||||||
| Ejection fraction decreased | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Dehydration | 3/22 (13.6%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Rhabdomyolysis | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Lymphoma | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Myelodysplastic syndrome | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Nervous system disorders | ||||||||||
| Carotid artery stenosis | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Balance disorder | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Encephalopathy | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Psychiatric disorders | ||||||||||
| Confusional state | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Hallucination, visual | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Urinary retention | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Renal failure acute | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Calculus ureteric | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Dyspnoea | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Respiratory failure | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Palmar-plantar erythrodysaesthesia syndrome | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Vascular disorders | ||||||||||
| Deep vein thrombosis | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Alisertib 50 mg BID Starting Dose (DLBL) | Alisertib 50 mg BID Starting Dose (MCL) | Alisertib 50 mg BID Starting Dose (TFL) | Alisertib 50 mg BID Starting Dose (BL) | Alisertib 50 mg BID Starting Dose (ATL) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/22 (100%) | 13/13 (100%) | 5/5 (100%) | 1/1 (100%) | 7/7 (100%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Neutropenia | 16/22 (72.7%) | 9/13 (69.2%) | 4/5 (80%) | 1/1 (100%) | 4/7 (57.1%) | |||||
| Anaemia | 15/22 (68.2%) | 7/13 (53.8%) | 3/5 (60%) | 1/1 (100%) | 5/7 (71.4%) | |||||
| Leukopenia | 13/22 (59.1%) | 8/13 (61.5%) | 3/5 (60%) | 1/1 (100%) | 4/7 (57.1%) | |||||
| Thrombocytopenia | 10/22 (45.5%) | 5/13 (38.5%) | 3/5 (60%) | 1/1 (100%) | 5/7 (71.4%) | |||||
| Lymphopenia | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Pancytopenia | 1/22 (4.5%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Splenomegaly | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Cardiac disorders | ||||||||||
| Tachycardia | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Atrial fibrillation | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Cardiac failure congestive | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Right ventricular hypertrophy | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Tinnitus | 1/22 (4.5%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Eye disorders | ||||||||||
| Vision blurred | 1/22 (4.5%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Lacrimation increased | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Night blindness | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Conjunctivitis | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Diarrhoea | 14/22 (63.6%) | 8/13 (61.5%) | 3/5 (60%) | 1/1 (100%) | 3/7 (42.9%) | |||||
| Stomatitis | 7/22 (31.8%) | 2/13 (15.4%) | 2/5 (40%) | 1/1 (100%) | 3/7 (42.9%) | |||||
| Nausea | 6/22 (27.3%) | 2/13 (15.4%) | 1/5 (20%) | 0/1 (0%) | 4/7 (57.1%) | |||||
| Vomiting | 5/22 (22.7%) | 3/13 (23.1%) | 1/5 (20%) | 0/1 (0%) | 4/7 (57.1%) | |||||
| Abdominal pain | 5/22 (22.7%) | 2/13 (15.4%) | 1/5 (20%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Constipation | 6/22 (27.3%) | 1/13 (7.7%) | 1/5 (20%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Dyspepsia | 3/22 (13.6%) | 2/13 (15.4%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Abdominal discomfort | 3/22 (13.6%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Abdominal pain upper | 1/22 (4.5%) | 2/13 (15.4%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Flatulence | 2/22 (9.1%) | 2/13 (15.4%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Dysphagia | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Ascites | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Gastrooesophageal reflux disease | 1/22 (4.5%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Haematochezia | 1/22 (4.5%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Mouth ulceration | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Oral pain | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Abdominal distension | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Epigastric discomfort | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Odynophagia | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Oesophagitis | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Swollen tongue | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| General disorders | ||||||||||
| Fatigue | 12/22 (54.5%) | 9/13 (69.2%) | 4/5 (80%) | 0/1 (0%) | 6/7 (85.7%) | |||||
| Asthenia | 5/22 (22.7%) | 1/13 (7.7%) | 2/5 (40%) | 0/1 (0%) | 3/7 (42.9%) | |||||
| Oedema peripheral | 4/22 (18.2%) | 1/13 (7.7%) | 1/5 (20%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Pyrexia | 6/22 (27.3%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Catheter site erythema | 3/22 (13.6%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Gait disturbance | 0/22 (0%) | 1/13 (7.7%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Chills | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Hepatobiliary disorders | ||||||||||
| Hyperbilirubinaemia | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Infections and infestations | ||||||||||
| Upper respiratory tract infection | 2/22 (9.1%) | 4/13 (30.8%) | 0/5 (0%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Cellulitis | 1/22 (4.5%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Oral candidiasis | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Urinary tract infection | 3/22 (13.6%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Fungal skin infection | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Herpes simplex | 0/22 (0%) | 1/13 (7.7%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Localised infection | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Eye infection | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Herpes dermatitis | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Oral herpes | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Sinusitis | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Herpes zoster | 1/22 (4.5%) | 2/13 (15.4%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Fall | 1/22 (4.5%) | 1/13 (7.7%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Contusion | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Laceration | 0/22 (0%) | 0/13 (0%) | 2/5 (40%) | 0/1 (0%) | 0/7 (0%) | |||||
| Muscle strain | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Tooth fracture | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Investigations | ||||||||||
| Alanine aminotransferase increased | 6/22 (27.3%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Aspartate aminotransferase increased | 6/22 (27.3%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Blood alkaline phosphatase increased | 6/22 (27.3%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Neutrophil count decreased | 3/22 (13.6%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 3/7 (42.9%) | |||||
| White blood cell count decreased | 3/22 (13.6%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Haemoglobin decreased | 4/22 (18.2%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Blood lactate dehydrogenase increased | 3/22 (13.6%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Weight decreased | 2/22 (9.1%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Activated partial thromboplastin time prolonged | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Blood creatinine increased | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Blood potassium decreased | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Platelet count decreased | 1/22 (4.5%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Blood albumin decreased | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Blood bilirubin increased | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| International normalised ratio decreased | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| International normalised ratio increased | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Mean cell volume increased | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Urine colour abnormal | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Decreased appetite | 7/22 (31.8%) | 2/13 (15.4%) | 0/5 (0%) | 1/1 (100%) | 3/7 (42.9%) | |||||
| Dehydration | 3/22 (13.6%) | 1/13 (7.7%) | 0/5 (0%) | 1/1 (100%) | 3/7 (42.9%) | |||||
| Hypokalaemia | 3/22 (13.6%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Hypoglycaemia | 3/22 (13.6%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Hypomagnesaemia | 3/22 (13.6%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Hypoalbuminaemia | 1/22 (4.5%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Hypercalcaemia | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Hyperuricaemia | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Hypophosphataemia | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Hypernatraemia | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Muscle spasms | 1/22 (4.5%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Musculoskeletal pain | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Pain in extremity | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Musculoskeletal chest pain | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Muscular weakness | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Myalgia | 2/22 (9.1%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Back pain | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Nervous system disorders | ||||||||||
| Somnolence | 9/22 (40.9%) | 4/13 (30.8%) | 2/5 (40%) | 1/1 (100%) | 5/7 (71.4%) | |||||
| Dizziness | 2/22 (9.1%) | 2/13 (15.4%) | 3/5 (60%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Headache | 2/22 (9.1%) | 1/13 (7.7%) | 1/5 (20%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Amnesia | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Sinus headache | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Syncope | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Tremor | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Ataxia | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Carotid artery aneurysm | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Cognitive disorder | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Dizziness postural | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Dysgeusia | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Hyperreflexia | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Mental impairment | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Paraesthesia | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Restless legs syndrome | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Sedation | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Memory Impairment | 2/22 (9.1%) | 3/13 (23.1%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Psychiatric disorders | ||||||||||
| Insomnia | 0/22 (0%) | 4/13 (30.8%) | 0/5 (0%) | 0/1 (0%) | 3/7 (42.9%) | |||||
| Confusional state | 3/22 (13.6%) | 1/13 (7.7%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Depression | 1/22 (4.5%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Attention deficit | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Anxiety | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Nephrolithiasis | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Urinary incontinence | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 1/1 (100%) | 0/7 (0%) | |||||
| Renal failure | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Dyspnoea | 4/22 (18.2%) | 1/13 (7.7%) | 2/5 (40%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Cough | 3/22 (13.6%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Dyspnoea exertional | 3/22 (13.6%) | 1/13 (7.7%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Oropharyngeal pain | 3/22 (13.6%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Pleural effusion | 2/22 (9.1%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Nasal congestion | 1/22 (4.5%) | 1/13 (7.7%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Atelectasis | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Dysphonia | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Epistaxis | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Productive cough | 1/22 (4.5%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Pulmonary oedema | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Hypoxia | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Oropharyngeal plaque | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Orthopnoea | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Rhinitis allergic | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Sinus congestion | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Tonsillar hypertrophy | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Alopecia | 9/22 (40.9%) | 8/13 (61.5%) | 4/5 (80%) | 1/1 (100%) | 1/7 (14.3%) | |||||
| Rash pruritic | 1/22 (4.5%) | 3/13 (23.1%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Night sweats | 3/22 (13.6%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Pruritus | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Blister | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 2/7 (28.6%) | |||||
| Decubitus ulcer | 1/22 (4.5%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Drug eruption | 1/22 (4.5%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Erythema | 1/22 (4.5%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Hyperhidrosis | 2/22 (9.1%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Rash papular | 1/22 (4.5%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Dermal cyst | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Dry skin | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Increased tendency to bruise | 0/22 (0%) | 1/13 (7.7%) | 0/5 (0%) | 0/1 (0%) | 0/7 (0%) | |||||
| Petechiae | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Rash erythematous | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 1/1 (100%) | 0/7 (0%) | |||||
| Skin discolouration | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Skin irritation | 0/22 (0%) | 0/13 (0%) | 1/5 (20%) | 0/1 (0%) | 0/7 (0%) | |||||
| Skin lesion | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Urticaria | 0/22 (0%) | 0/13 (0%) | 0/5 (0%) | 0/1 (0%) | 1/7 (14.3%) | |||||
| Vascular disorders | ||||||||||
| Hypotension | 6/22 (27.3%) | 1/13 (7.7%) | 1/5 (20%) | 0/1 (0%) | 1/7 (14.3%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Takeda |
| Phone | +1-877-825-3327 |
| trialdisclosures@takeda.com |
Responsible Party:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00807495
Other Study ID Numbers:
- C14004
- U1111-1187-1268
First Posted:
Dec 12, 2008
Last Update Posted:
Mar 27, 2018
Last Verified:
Feb 1, 2018