Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma
Sponsor
Eisai Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01335009
Collaborator
(none)
76
29
2
106.8
2.6
0
Study Details
Study Description
Brief Summary
This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess progression free survival in subjects with metastatic melanoma.
Approximately 80 subjects at 29 sites in the U.S., U.K., Germany and Australia will be randomized into one of two dose groups: 2 mg/kg, 4 mg/kg. Weekly treatment will continue until disease progression.
Subjects must have measurable disease by CT Scan or MRI and must have completed at least one prior round of chemotherapy.
Subjects will be assessed for Efficacy, PK/PD, Overall survival, and Safety (Adverse Events/Adverse Events of Interest, Electrocardiograms (ECG's), clinical labs, physical exams/vital signs, tolerability).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
MORAb-004 is a monoclonal antibody directed against endosialin, a cell surface glycoprotein, which is expressed on cells involved in tumor vasculature. Studies have found endosialin to play a key role in tumor growth and neovessel formation in numerous cancer types including melanoma. Preclinical pharmacological studies have shown that MORAb-004 is a potentially useful anti-cancer agent. This clinical trial is being performed to determine the efficacy of MORAb-004 at two dose levels in subjects with metastatic melanoma, as well as to establish serum pharmacokinetics and pharmacodynamics of the antibody.
Study Design
Study Type:
Interventional
Actual Enrollment
:
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects With Metastatic Melanoma
Actual Study Start Date
:
May 16, 2011
Actual Primary Completion Date
:
Dec 2, 2013
Actual Study Completion Date
:
Apr 10, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MORAb-004, 2 mg/kg Biologic (monoclonal antibody) |
Biological: MORAb-004 (monoclonal antibody)
Subjects will receive one cycle of treatment with MORAb-004, administered intravenously, on Days 1, 8, 15, and 22 (4 administrations per cycle). Additional cycles will continue without interruption until disease progression occurs or clinical or symptomatic progression as suggested by an investigator.
|
| Experimental: MORAb-004, 4 mg/kg Biologic (monoclonal antibody) |
Biological: MORAb-004 (monoclonal antibody)
Subjects will receive one cycle of treatment with MORAb-004, administered intravenously, on Days 1, 8, 15, and 22 (4 administrations per cycle). Additional cycles will continue without interruption until disease progression occurs or clinical or symptomatic progression as suggested by an investigator.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Progression-free Survival (PFS) at Week 24 [Week 24]
PFS was defined as the time (in weeks) from the date of randomization to the date of the first sign of disease progression (PD) based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, or date of death, regardless of cause. PD greater than or equal to (>=) 20 percent (%) increase in the nadir of total tumor burden (TTB) (minimum 5 millimeter [mm]). Participants who were alive with no disease progression had their PFS time censored at the date of their last tumor assessment. Participants who received a new anti-cancer therapy before disease progression had their PFS time censored at the date of their last tumor assessment before the new anti-cancer therapy was started. PFS was analyzed using Kaplan Meier method.
Secondary Outcome Measures
- Percentage of Participants With PFS at Weeks 16 and 52 [Week 16 and Week 52]
PFS was defined as the time (in weeks) from the date of randomization to the date of the first observation of PD (RECIST version 1.1) or date of death, regardless of the cause. PD >=20% increase in the nadir of TTB (minimum 5 mm). Participants who were alive with no disease progression had their PFS time censored at the date of their last tumor assessment. Participants who received new anti-cancer therapy before disease progression had their PFS time censored at the date of their last tumor assessment before the new anti-cancer therapy was initiated. PFS was based on the Kaplan-Meier method.
- Overall Survival (OS) [Date of first study treatment (Day 1) to date of death or up to approximately 2 years 7 months]
OS was defined as the time (in weeks) from the date of randomization to the date of death, regardless of cause. In the absence of death confirmation, or for participants alive at the time of analysis, the survival time was censored at the date of the last study follow-up. OS was calculated using the Kaplan-Meier method. As per planned analysis, efficacy outcomes was planned to be analyzed until cut-off date (02 December 2013).
- Percentage of Participants With Overall Response [Date of first study treatment (Day 1) to complete response or partial response, assessed up to approximately 2 years 7 months]
ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) that occurred (defined by RECIST version 1.1) using CT/MRI. Per RECIST 1.1, CR= disappearance of all lesions; PR greater than or equal to (>=) 30percent (%) decrease from baseline in TTB. As per planned analysis, efficacy outcomes was planned to be analyzed until cut-off date (02 December 2013).
- Optimal Biologic Dosing (OBD) of Morab-004 [Day 1 Cycle 1 (Cycle length = 28 days)]
OBD is defined as the dose level/exposure level at which three parameters are met: 1) adequate pharmacokinetic (PK) profile with a serum half-life (t1/2) of >=48 hours, 2) at least minimal demonstration of antitumor efficacy (50% or greater PFS rate at 16 weeks), and 3) change of 25% or greater from baseline value in any of the pharmacodynamic (PD) parameters assessed in the study in 30% of participants at that dose level.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period.
-
Histologically confirmed diagnosis of metastatic melanoma
-
At least 1 prior systemic treatment for metastatic melanoma with disease progression following treatment
-
Measurable disease, as defined by RECIST v1.1, assessed within 4 weeks prior to study entry
-
At least 3 week interval between first infusion of test article and most recent prior systemic anticancer therapy. All treatment-associated toxicity must be resolved to less than or equal to Grade 1 before the administration of MORAb-004
-
Have a life expectancy of at least 3 months as estimated by the investigator
-
Have other significant medical conditions well-controlled and stable, in the opinion of the investigator, for at least 30 days prior to Study Day 1
-
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
-
Have sites of disease amenable to the protocol-specified biopsy (Note: All participants will have protocol-specified biopsy at Screening. The second, on-treatment biopsy will be mandatory in the first 30 randomized participants only. For all other participants, the second biopsy is optional.
-
Laboratory tests results prior to Study Day 1 within limits as outlined in protocol
Exclusion Criteria:
-
Have received no prior systemic treatment for metastatic melanoma
-
Evidence of other active malignancy requiring treatment within the last 5 years (other than basal cell or squamous cell carcinoma of the skin), or active brain metastasis
-
Clinically significant heart disease (Congestive heart failure of New York Heart Association [NYHA] Class 3 or 4, angina not well controlled by medication, or myocardial infarction within 6 mos.), or ECGs demonstrating clinically significant arrhythmias
-
Have any other serious systemic disease, including active bacterial or fungal infection, or any medical condition requiring cytotoxic therapy or chronic (at least 4 consecutive weeks) systemic corticosteroid use
-
Have active viral hepatitis or symptomatic Human immunodeficiency virus (HIV) infection
-
Be breast-feeding, pregnant, or likely to become pregnant during the study
-
Known allergic reaction to a prior monoclonal antibody therapy
-
Previous treatment with MORAb-004
-
Brain metastasis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pinnacle Oncology | Scottsdale | Arizona | United States | 19454 |
| 2 | The Angeles Clinic and Research Institute | Los Angeles | California | United States | 90025 |
| 3 | University of California Los Angeles | Los Angeles | California | United States | 90095 |
| 4 | University of Colorado Cancer Center, Anschutz Cancer Pavilion | Aurora | Colorado | United States | 80045 |
| 5 | Yale University | New Haven | Connecticut | United States | 06520 |
| 6 | The University Of Chicago | Chicago | Illinois | United States | 60637 |
| 7 | Oncology Specialists, SC | Park Ridge | Illinois | United States | 60068 |
| 8 | University of Iowa Hospital | Iowa City | Iowa | United States | 52242 |
| 9 | University of Minnesota | Minneapolis | Minnesota | United States | 19454 |
| 10 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 11 | Atlantic Health | Morristown | New Jersey | United States | 07962 |
| 12 | New York University Cancer Institute | New York | New York | United States | 10016 |
| 13 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
| 14 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 19454 |
| 15 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 16 | St. Luke's Hospital & Health Network | Bethlehem | Pennsylvania | United States | 18051 |
| 17 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
| 18 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 19 | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | United States | 15232 |
| 20 | University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112 |
| 21 | Sydney Cancer Center - Royal Prince Alfred Hospital | Camperdown | New South Wales | Australia | 2050 |
| 22 | Newcastle Melanoma Unit, Calvery Mater Newcastle | Waratah | New South Wales | Australia | 2298 |
| 23 | The Crown Princess Mary Cancer Centre, Westmead Hospital | Westmead | New South Wales | Australia | 2145 |
| 24 | Princess Alexandra Hospital | Woolloongabba | Queensland | Australia | 4102 |
| 25 | Universitatsklinikum Essen, Klinik fur Dermatologie | Essen | Germany | 45147 | |
| 26 | Universitats-Hautklinik | Mainz | Germany | 55131 | |
| 27 | Eberhard Karls University Tuebingen | Tuebingen | Germany | 72076 | |
| 28 | The Royal Marsden Hospital | London | United Kingdom | SW3 6JJ | |
| 29 | Weston Park Hospital | Sheffield | United Kingdom | S10 2SJ |
Sponsors and Collaborators
- Eisai Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01335009
Other Study ID Numbers:
- MORAb-004-201MEL
- 2011-001282-40
First Posted:
Apr 13, 2011
Last Update Posted:
Sep 1, 2021
Last Verified:
Apr 1, 2021
Keywords provided by Eisai Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants took part in the study at 29 sites in 4 countries (the United States, Australia, Germany, and the United Kingdom), 20 of which enrolled participants. |
|---|---|
| Pre-assignment Detail | A total of 76 participants were randomized to treatment with MORAb-004 (40 participants in the 2 milligram per kilogram [mg/kg] group and 36 participants in the 4 mg/kg group). |
| Arm/Group Title | MORAb-004 2 mg/kg | MORAb-004 4 mg/kg |
|---|---|---|
| Arm/Group Description | Participants received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using computed tomography/magnetic resonance imaging (CT/MRI) or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. | Participants received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. |
| Period Title: Overall Study | ||
| STARTED | 40 | 36 |
| COMPLETED | 9 | 3 |
| NOT COMPLETED | 31 | 33 |
Baseline Characteristics
| Arm/Group Title | MORAb-004 2 mg/kg | MORAb-004 4 mg/kg | Total |
|---|---|---|---|
| Arm/Group Description | Participants received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. | Participants received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. | Total of all reporting groups |
| Overall Participants | 40 | 36 | 76 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
65.1
(12.22)
|
61.2
(12.15)
|
63.3
(12.26)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
18
45%
|
9
25%
|
27
35.5%
|
| Male |
22
55%
|
27
75%
|
49
64.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
1
2.5%
|
4
11.1%
|
5
6.6%
|
| Not Hispanic or Latino |
39
97.5%
|
32
88.9%
|
71
93.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
1
2.8%
|
1
1.3%
|
| White |
39
97.5%
|
34
94.4%
|
73
96.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
2.5%
|
1
2.8%
|
2
2.6%
|
Outcome Measures
| Title | Percentage of Participants With Progression-free Survival (PFS) at Week 24 |
|---|---|
| Description | PFS was defined as the time (in weeks) from the date of randomization to the date of the first sign of disease progression (PD) based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, or date of death, regardless of cause. PD greater than or equal to (>=) 20 percent (%) increase in the nadir of total tumor burden (TTB) (minimum 5 millimeter [mm]). Participants who were alive with no disease progression had their PFS time censored at the date of their last tumor assessment. Participants who received a new anti-cancer therapy before disease progression had their PFS time censored at the date of their last tumor assessment before the new anti-cancer therapy was started. PFS was analyzed using Kaplan Meier method. |
| Time Frame | Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Primary efficacy population included all participants in the safety population who meet all key eligibility criteria (including measurable disease at baseline after at least 1 systemic treatment) analyzed by the dose level to which they were randomized. |
| Arm/Group Title | MORAb-004 2 mg/kg | MORAb-004 4 mg/kg |
|---|---|---|
| Arm/Group Description | Participants received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. | Participants received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. |
| Measure Participants | 39 | 36 |
| Number (95% Confidence Interval) [percentage of participants] |
13.5
33.8%
|
8.9
24.7%
|
| Title | Percentage of Participants With PFS at Weeks 16 and 52 |
|---|---|
| Description | PFS was defined as the time (in weeks) from the date of randomization to the date of the first observation of PD (RECIST version 1.1) or date of death, regardless of the cause. PD >=20% increase in the nadir of TTB (minimum 5 mm). Participants who were alive with no disease progression had their PFS time censored at the date of their last tumor assessment. Participants who received new anti-cancer therapy before disease progression had their PFS time censored at the date of their last tumor assessment before the new anti-cancer therapy was initiated. PFS was based on the Kaplan-Meier method. |
| Time Frame | Week 16 and Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Primary efficacy population included all participants in the safety population who meet all key eligibility criteria (including measurable disease at baseline after at least 1 systemic treatment) analyzed by the dose level to which they were randomized. |
| Arm/Group Title | MORAb-004 2 mg/kg | MORAb-004 4 mg/kg |
|---|---|---|
| Arm/Group Description | Participants received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. | Participants received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. |
| Measure Participants | 39 | 36 |
| Week 16 |
32.5
81.3%
|
20.8
57.8%
|
| Week 52 |
NA
NaN
|
8.9
24.7%
|
| Title | Overall Survival (OS) |
|---|---|
| Description | OS was defined as the time (in weeks) from the date of randomization to the date of death, regardless of cause. In the absence of death confirmation, or for participants alive at the time of analysis, the survival time was censored at the date of the last study follow-up. OS was calculated using the Kaplan-Meier method. As per planned analysis, efficacy outcomes was planned to be analyzed until cut-off date (02 December 2013). |
| Time Frame | Date of first study treatment (Day 1) to date of death or up to approximately 2 years 7 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Primary efficacy population included all participants in the safety population who meet all key eligibility criteria (including measurable disease at baseline after at least 1 systemic treatment) analyzed by the dose level to which they were randomized. Participants without documentation of death at the time of analysis were censored at the date last known to be alive. |
| Arm/Group Title | MORAb-004 2 mg/kg | MORAb-004 4 mg/kg |
|---|---|---|
| Arm/Group Description | Participants received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. | Participants received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. |
| Measure Participants | 39 | 36 |
| Median (95% Confidence Interval) [weeks] |
40.9
|
29.3
|
| Title | Percentage of Participants With Overall Response |
|---|---|
| Description | ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) that occurred (defined by RECIST version 1.1) using CT/MRI. Per RECIST 1.1, CR= disappearance of all lesions; PR greater than or equal to (>=) 30percent (%) decrease from baseline in TTB. As per planned analysis, efficacy outcomes was planned to be analyzed until cut-off date (02 December 2013). |
| Time Frame | Date of first study treatment (Day 1) to complete response or partial response, assessed up to approximately 2 years 7 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| ORR population included a subset of participants from the primary efficacy population who had at least 1 on-study radiologic evaluation performed (in addition to their baseline evaluation), analyzed by the dose level received. |
| Arm/Group Title | MORAb-004 2 mg/kg | MORAb-004 4 mg/kg |
|---|---|---|
| Arm/Group Description | Participants received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. | Participants received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. |
| Measure Participants | 34 | 32 |
| Number (95% Confidence Interval) [percentage of participants] |
NA
NaN
|
3.1
8.6%
|
| Title | Optimal Biologic Dosing (OBD) of Morab-004 |
|---|---|
| Description | OBD is defined as the dose level/exposure level at which three parameters are met: 1) adequate pharmacokinetic (PK) profile with a serum half-life (t1/2) of >=48 hours, 2) at least minimal demonstration of antitumor efficacy (50% or greater PFS rate at 16 weeks), and 3) change of 25% or greater from baseline value in any of the pharmacodynamic (PD) parameters assessed in the study in 30% of participants at that dose level. |
| Time Frame | Day 1 Cycle 1 (Cycle length = 28 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the safety population who receive at least one dose of MORAb-004 and who had at least one on-treatment PK/PD assessment performed that is sufficient to evaluate the endpoint of interest. Here "overall number of participants analyzed" are participants who were available for this outcome measure. |
| Arm/Group Title | MORAb-004 2 mg/kg | MORAb-004 4 mg/kg |
|---|---|---|
| Arm/Group Description | Participants received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. | Participants received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. |
| Measure Participants | 39 | 36 |
| Number [milligram(s)] |
NA
|
NA
|
Adverse Events
| Time Frame | From the first dose of study drug to 45 days after the last dose of study drug (up to approximately 8 years 11 months) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Safety population included all randomized participants who received at least 1 dose of study drug, analyzed by the actual treatment received. The severity of AE toxicities was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria, v4.03, where applicable. | |||
| Arm/Group Title | MORAb-004 2 mg/kg | MORAb-004 4 mg/kg | ||
| Arm/Group Description | Participants received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. | Participants received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. | ||
All Cause Mortality |
||||
| MORAb-004 2 mg/kg | MORAb-004 4 mg/kg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 28/40 (70%) | 32/36 (88.9%) | ||
Serious Adverse Events |
||||
| MORAb-004 2 mg/kg | MORAb-004 4 mg/kg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/40 (42.5%) | 16/36 (44.4%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 2/40 (5%) | 2 | 1/36 (2.8%) | 1 |
| Cardiac disorders | ||||
| Acute myocardial infarction | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Atrial fibrillation | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Bradycardia | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Pericardial effusion | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Nausea | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Small intestinal obstruction | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| General disorders | ||||
| Infusion related reaction | 0/40 (0%) | 0 | 2/36 (5.6%) | 2 |
| Pyrexia | 0/40 (0%) | 0 | 2/36 (5.6%) | 2 |
| Chills | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Fatigue | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Delirium | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Cholecystitis acute | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Immune system disorders | ||||
| Hypersensitivity | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Infections and infestations | ||||
| Cellulitis | 1/40 (2.5%) | 1 | 3/36 (8.3%) | 3 |
| Sepsis | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Septic shock | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Urosepsis | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Wound infection | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Tumour haemorrhage | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Pneumonia | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Tibia fracture | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Hyponatraemia | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Pain in extremity | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Metastatic malignant melanoma | 3/40 (7.5%) | 3 | 0/36 (0%) | 0 |
| Neuroendocrine carcinoma of the skin | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Squamous cell carcinoma | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Malignant neoplasm progression | 1/40 (2.5%) | 1 | 3/36 (8.3%) | 3 |
| Nervous system disorders | ||||
| Brain oedema | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Syncope | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Toxic encephalopathy | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Psychiatric disorders | ||||
| Confusional state | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Mental status changes | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Renal and urinary disorders | ||||
| Hydronephrosis | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pulmonary embolism | 2/40 (5%) | 2 | 1/36 (2.8%) | 1 |
| Pleural effusion | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Respiratory failure | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Vascular disorders | ||||
| Lymphoedema | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Deep vein thrombosis | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| MORAb-004 2 mg/kg | MORAb-004 4 mg/kg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 40/40 (100%) | 36/36 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 8/40 (20%) | 16 | 10/36 (27.8%) | 22 |
| Leukocytosis | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Lymph node pain | 2/40 (5%) | 5 | 0/36 (0%) | 0 |
| Thrombocytopenia | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Lymphopenia | 0/40 (0%) | 0 | 2/36 (5.6%) | 5 |
| Atrial flutter | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Cardiac disorders | ||||
| Arrhythmia supraventricular | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Sinus bradycardia | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Sinus tachycardia | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Ear and labyrinth disorders | ||||
| Vertigo | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Eye disorders | ||||
| Diabetic retinopathy | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Eye discharge | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Eye pain | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Macular oedema | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Vision blurred | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Vitreous haemorrhage | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Conjunctival oedema | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Gastrointestinal disorders | ||||
| Nausea | 13/40 (32.5%) | 18 | 15/36 (41.7%) | 21 |
| Constipation | 9/40 (22.5%) | 11 | 9/36 (25%) | 9 |
| Vomiting | 3/40 (7.5%) | 3 | 9/36 (25%) | 12 |
| Abdominal pain | 5/40 (12.5%) | 5 | 5/36 (13.9%) | 6 |
| Diarrhoea | 4/40 (10%) | 4 | 6/36 (16.7%) | 10 |
| Dyspepsia | 4/40 (10%) | 4 | 3/36 (8.3%) | 4 |
| Abdominal discomfort | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Abdominal pain lower | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Abdominal pain upper | 2/40 (5%) | 2 | 1/36 (2.8%) | 3 |
| Abdominal tenderness | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Colitis | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Dental caries | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Dry mouth | 2/40 (5%) | 2 | 1/36 (2.8%) | 1 |
| Frequent bowel movements | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Gastrooesophageal reflux disease | 0/40 (0%) | 0 | 2/36 (5.6%) | 2 |
| Gingival bleeding | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Haematochezia | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Intussusception | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Stomatitis | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Toothache | 0/40 (0%) | 0 | 2/36 (5.6%) | 2 |
| Dysphagia | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Flatulence | 2/40 (5%) | 2 | 0/36 (0%) | 0 |
| Abdominal distension | 0/40 (0%) | 0 | 1/36 (2.8%) | 2 |
| General disorders | ||||
| Fatigue | 18/40 (45%) | 28 | 18/36 (50%) | 28 |
| Chills | 13/40 (32.5%) | 13 | 18/36 (50%) | 20 |
| Pyrexia | 9/40 (22.5%) | 11 | 12/36 (33.3%) | 17 |
| Infusion related reaction | 4/40 (10%) | 4 | 1/36 (2.8%) | 3 |
| Oedema peripheral | 4/40 (10%) | 4 | 3/36 (8.3%) | 6 |
| Influenza like illness | 3/40 (7.5%) | 3 | 1/36 (2.8%) | 1 |
| Feeling cold | 2/40 (5%) | 2 | 0/36 (0%) | 0 |
| Feeling hot | 2/40 (5%) | 2 | 0/36 (0%) | 0 |
| Hernia | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Infusion site extravasation | 1/40 (2.5%) | 1 | 2/36 (5.6%) | 2 |
| Localised oedema | 0/40 (0%) | 0 | 1/36 (2.8%) | 2 |
| Pain | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Swelling | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Asthenia | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Immune system disorders | ||||
| Drug hypersensitivity | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Hypersensitivity | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Seasonal allergy | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Infections and infestations | ||||
| Urinary tract infection | 2/40 (5%) | 2 | 5/36 (13.9%) | 5 |
| Cellulitis | 2/40 (5%) | 2 | 0/36 (0%) | 0 |
| Cystitis | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Folliculitis | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Fungal skin infection | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Gastroenteritis | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Herpes zoster | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Infection | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Influenza | 2/40 (5%) | 2 | 0/36 (0%) | 0 |
| Lung infection | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Nasopharyngitis | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Oral candidiasis | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Oral herpes | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Pneumonia | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Rhinitis | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Sinusitis | 2/40 (5%) | 2 | 0/36 (0%) | 0 |
| Skin infection | 0/40 (0%) | 0 | 2/36 (5.6%) | 2 |
| Upper respiratory tract infection | 3/40 (7.5%) | 3 | 1/36 (2.8%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Procedural pain | 3/40 (7.5%) | 3 | 1/36 (2.8%) | 1 |
| Contusion | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Excoriation | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Incision site pain | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Joint dislocation | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Joint sprain | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Skin laceration | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Tongue injury | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Investigations | ||||
| Alanine aminotransferase increased | 1/40 (2.5%) | 1 | 2/36 (5.6%) | 2 |
| Aspartate aminotransferase increased | 1/40 (2.5%) | 1 | 2/36 (5.6%) | 2 |
| Blood alkaline phosphatase increased | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Blood bilirubin increased | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Blood creatinine increased | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Blood glucose increased | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Blood pressure increased | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Blood urea increased | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Blood uric acid increased | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Blood urine present | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Breath sounds abnormal | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Electrocardiogram QT prolonged | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Electrocardiogram RR interval prolonged | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Eosinophil count increased | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| International normalised ratio increased | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Lipase increased | 1/40 (2.5%) | 2 | 0/36 (0%) | 0 |
| Lymphocyte count decreased | 0/40 (0%) | 0 | 1/36 (2.8%) | 2 |
| Protein urine present | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Prothrombin time prolonged | 1/40 (2.5%) | 2 | 0/36 (0%) | 0 |
| QRS axis abnormal | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Respiratory rate increased | 0/40 (0%) | 0 | 2/36 (5.6%) | 2 |
| Specific gravity urine increased | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Weight decreased | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Weight increased | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| White blood cell count increased | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| White blood cells urine positive | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 9/40 (22.5%) | 14 | 11/36 (30.6%) | 12 |
| Hyponatraemia | 1/40 (2.5%) | 1 | 4/36 (11.1%) | 5 |
| Dehydration | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Hyperglycaemia | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Hyperlipidaemia | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Hypocalcaemia | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Hypoalbuminaemia | 2/40 (5%) | 2 | 1/36 (2.8%) | 1 |
| Hypokalaemia | 2/40 (5%) | 2 | 2/36 (5.6%) | 2 |
| Hypophosphataemia | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 9/40 (22.5%) | 10 | 5/36 (13.9%) | 6 |
| Back pain | 5/40 (12.5%) | 5 | 9/36 (25%) | 9 |
| Pain in extremity | 4/40 (10%) | 5 | 3/36 (8.3%) | 3 |
| Myalgia | 1/40 (2.5%) | 3 | 3/36 (8.3%) | 3 |
| Arthritis | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Flank pain | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Joint stiffness | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Muscle spasms | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Muscular weakness | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Musculoskeletal pain | 1/40 (2.5%) | 1 | 5/36 (13.9%) | 5 |
| Musculoskeletal stiffness | 0/40 (0%) | 0 | 2/36 (5.6%) | 2 |
| Neck pain | 0/40 (0%) | 0 | 1/36 (2.8%) | 2 |
| Osteoarthritis | 2/40 (5%) | 3 | 0/36 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Tumour pain | 6/40 (15%) | 10 | 1/36 (2.8%) | 1 |
| Nervous system disorders | ||||
| Headache | 21/40 (52.5%) | 35 | 21/36 (58.3%) | 31 |
| Dizziness | 3/40 (7.5%) | 4 | 4/36 (11.1%) | 4 |
| Tremor | 2/40 (5%) | 2 | 2/36 (5.6%) | 2 |
| Aphasia | 0/40 (0%) | 0 | 1/36 (2.8%) | 2 |
| Balance disorder | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Brain oedema | 1/40 (2.5%) | 2 | 0/36 (0%) | 0 |
| Coma | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Disturbance in attention | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Dysgeusia | 1/40 (2.5%) | 1 | 2/36 (5.6%) | 2 |
| Dyskinesia | 0/40 (0%) | 0 | 1/36 (2.8%) | 2 |
| Hypoaesthesia | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Memory impairment | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Neuralgia | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Paraesthesia | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Peripheral sensory neuropathy | 2/40 (5%) | 4 | 0/36 (0%) | 0 |
| Sciatica | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Sinus headache | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Somnolence | 1/40 (2.5%) | 1 | 2/36 (5.6%) | 4 |
| Psychiatric disorders | ||||
| Anxiety | 2/40 (5%) | 2 | 4/36 (11.1%) | 4 |
| Confusional state | 0/40 (0%) | 0 | 4/36 (11.1%) | 6 |
| Agitation | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Depression | 1/40 (2.5%) | 1 | 2/36 (5.6%) | 2 |
| Disorientation | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Insomnia | 0/40 (0%) | 0 | 2/36 (5.6%) | 2 |
| Mood altered | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Nightmare | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Renal and urinary disorders | ||||
| Dysuria | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Haematuria | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Hypertonic bladder | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Proteinuria | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Urinary retention | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Reproductive system and breast disorders | ||||
| Balanitis | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Scrotal oedema | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 5/40 (12.5%) | 9 | 8/36 (22.2%) | 9 |
| Dyspnoea | 4/40 (10%) | 6 | 6/36 (16.7%) | 7 |
| Dyspnoea exertional | 4/40 (10%) | 4 | 2/36 (5.6%) | 2 |
| Pulmonary embolism | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Upper respiratory tract infection | 3/40 (7.5%) | 3 | 1/36 (2.8%) | 1 |
| Epistaxis | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Nasal congestion | 3/40 (7.5%) | 3 | 0/36 (0%) | 0 |
| Oropharyngeal pain | 2/40 (5%) | 2 | 1/36 (2.8%) | 1 |
| Pleural effusion | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Pleuritic pain | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Postnasal drip | 1/40 (2.5%) | 2 | 0/36 (0%) | 0 |
| Productive cough | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Pulmonary congestion | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Pulmonary hypertension | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Rhinorrhoea | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Rhonchi | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Wheezing | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Erythema | 2/40 (5%) | 3 | 3/36 (8.3%) | 4 |
| Pruritus | 3/40 (7.5%) | 4 | 2/36 (5.6%) | 3 |
| Night sweats | 2/40 (5%) | 3 | 2/36 (5.6%) | 2 |
| Rash | 1/40 (2.5%) | 1 | 3/36 (8.3%) | 3 |
| Rash generalised | 1/40 (2.5%) | 2 | 0/36 (0%) | 0 |
| Rash macular | 1/40 (2.5%) | 3 | 0/36 (0%) | 0 |
| Alopecia | 1/40 (2.5%) | 2 | 0/36 (0%) | 0 |
| Blister | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Dry skin | 2/40 (5%) | 4 | 0/36 (0%) | 0 |
| Fungating wound | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Hyperhidrosis | 2/40 (5%) | 2 | 0/36 (0%) | 0 |
| Intertrigo | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Skin discolouration | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Skin disorder | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Skin exfoliation | 1/40 (2.5%) | 1 | 1/36 (2.8%) | 1 |
| Skin haemorrhage | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Subcutaneous nodule | 1/40 (2.5%) | 2 | 0/36 (0%) | 0 |
| Swelling face | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Vitiligo | 2/40 (5%) | 2 | 1/36 (2.8%) | 1 |
| Vascular disorders | ||||
| Hypertension | 1/40 (2.5%) | 1 | 3/36 (8.3%) | 3 |
| Deep vein thrombosis | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Flushing | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Hot flush | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Hypotension | 1/40 (2.5%) | 1 | 2/36 (5.6%) | 2 |
| Orthostatic hypotension | 0/40 (0%) | 0 | 1/36 (2.8%) | 1 |
| Vena cava thrombosis | 1/40 (2.5%) | 1 | 0/36 (0%) | 0 |
| Lymphoedema | 2/40 (5%) | 3 | 0/36 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Eisai Medical Information |
|---|---|
| Organization | Eisai Inc. |
| Phone | 18882742378 |
| esi_medinfo@eisai.com |
Responsible Party:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01335009
Other Study ID Numbers:
- MORAb-004-201MEL
- 2011-001282-40
First Posted:
Apr 13, 2011
Last Update Posted:
Sep 1, 2021
Last Verified:
Apr 1, 2021