SOURCE: Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation
Sponsor
Morphotek (Industry)
Overall Status
Completed
CT.gov ID
NCT01574716
Collaborator
(none)
209
29
2
47.8
7.2
0.2
Study Details
Study Description
Brief Summary
This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
209 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel With MORAb-004 in Metastatic Soft Tissue Sarcoma
Actual Study Start Date
:
Aug 7, 2012
Actual Primary Completion Date
:
Aug 11, 2015
Actual Study Completion Date
:
Aug 2, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MORAb-004, gemcitabine, docetaxel
|
Drug: MORAb-004
IV, Days 1 and 8 of every cycle until disease progression
Drug: Gemcitabine
IV, Days 1 and 8 of each cycle until disease progression
Drug: Docetaxel
IV, Day 8 of every cycle until disease progression
|
| Active Comparator: Placebo, gemcitabine, docetaxel
|
Drug: Gemcitabine
IV, Days 1 and 8 of each cycle until disease progression
Drug: Docetaxel
IV, Day 8 of every cycle until disease progression
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Part 2: Radiologic Progression-free Survival (PFS) [From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)]
PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause.
Secondary Outcome Measures
- Part 2: Symptomatic Progression-free Survival [From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years)]
PFS including symptomatic progression was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression according to RECIST 1.1, symptomatic progression, or death due to any cause.
- Part 2: Overall Survival (OS) [From date of first dose until date of death from any cause (up to approximately 3.5 years)]
OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause.
- Part 2: Overall Response Rate (ORR) [From date of first dose until disease progression (up to approximately 3.5 years)]
ORR was defined as the percentage of subjects with either a complete response (CR) or a partial response (PR) based on RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters.
- Part 2: Radiologic Progression-free Survival Rate (PFR) [Weeks 12, 24, 48 and 52]
Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points.
- Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels [Up to approximately 3 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Be at least 18 years of age
-
Be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period
-
Have a histologically confirmed diagnosis of mSTS as defined by the 4 specified study subgrouped
-
Have been treated in the metastatic setting with 0 to 2 prior systemic regimens for mSTS (Systemic treatment regimens given in the neoadjuvant setting and maintenance therapies will not be considered as regimens in the metastatic setting for the purposes of this protocol. Prior anthracycline-based regimen is allowable but not required. Subjects with extra-skeletal small round blue cell sarcomas, including rhabdomyosarcomas, must have exhausted or be intolerant of standard first line anthracycline-based chemotherapy.)
-
Have measurable disease, as defined by RECIST v 1.1 assess within 2 weeks of study entry and have radiologically documented disease progression greater than or equal to a 10% increase in the sum of the longest diameters of target lesions present within 6 months prior to randomization
-
Have tumor tissue available for TEM-1 biomarker studies
-
Be willing and able to provide written informed consent
Exclusion Criteria:
-
Have received more than 2 prior systemic treatment regimens for mSTS
-
Have received either gemcitabine or docetaxel in any previous treatment for mSTS (regardless of the line of treatment)
-
Have a diagnosis of primary bone sarcoma of any histological type.
-
Have a history of clinically significant heart disease, or clinically significant arrhythmia on ECG within the past 6 months
-
Have a history of allergic reaction to prior monoclonal antibody or biologic agent
-
Have received previous treatment with MORAb-004 (anti-TEM-1)
-
Have a medical condition with a high risk of bleeding (e.g., a known bleeding disorder, a coagulopathy, or a tumor that involves the major vessels) or have a recent (within past 6 months) history of a significant bleeding event
-
Have undergone major surgical procedures or open biopsy, have significant traumatic injury within 30 days prior to the first date of study treatment, or have major surgical procedures anticipated during the study
-
Have a serious non-healing wound, an ulcer (including gastrointestinal), or a bone fracture
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sarcoma Oncology Center | Santa Monica | California | United States | 90403 |
| 2 | UCLA | Santa Monica | California | United States | 90404 |
| 3 | Mayo Clinic Jacksonville | Jacksonville | Florida | United States | 32224 |
| 4 | University of Miami | Miami | Florida | United States | 33136 |
| 5 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
| 6 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
| 7 | Siouxland Hematology-Oncology | Sioux City | Iowa | United States | 51101 |
| 8 | Sidney Kimmel Comprehensive Cancer Center at John Hopkins | Baltimore | Maryland | United States | 21231 |
| 9 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 2215 |
| 10 | University of Michigan Health System | Ann Arbor | Michigan | United States | 48109 |
| 11 | Washington University | Saint Louis | Missouri | United States | 63110 |
| 12 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 13 | Mayo Clinic - Rochester | Rochester | New York | United States | 55905 |
| 14 | The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
| 15 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 16 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 17 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 18 | Huntsman Cancer Institute at the University of Utah | Salt Lake City | Utah | United States | 84112 |
| 19 | Seattle Care Alliance | Seattle | Washington | United States | |
| 20 | Canberra Hospital | Garran | Australian Capital Territory | Australia | 2605 |
| 21 | Royal North Shore Hospital | St. Leonards | New South Wales | Australia | 2065 |
| 22 | Princess Alexandra Hospital | Woolloongabba | Queensland | Australia | 4102 |
| 23 | Ashford Cancer Centre Research | Kurralta Park | South Australia | Australia | 5037 |
| 24 | Sir Charles Gairdner Hospital | Perth | Western Australia | Australia | 6009 |
| 25 | UZ Leuven Medical Oncology | Leuven | Belgium | 3000 | |
| 26 | Institut Gustave Roussy | Villejuif | France | 94805 | |
| 27 | University of Claude Bernard | Villeurbanne | France | 69100 | |
| 28 | Istituto Ortopedico Rizzoli | Bologna | Italy | 40136 | |
| 29 | Leiden University Medical Center | Leiden | Netherlands |
Sponsors and Collaborators
- Morphotek
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Morphotek
ClinicalTrials.gov Identifier:
NCT01574716
Other Study ID Numbers:
- MORAb-004-203-STS
- 2012-001399-12
First Posted:
Apr 10, 2012
Last Update Posted:
Aug 21, 2019
Last Verified:
Nov 1, 2016
Study Results
Participant Flow
| Recruitment Details | Participants took part in the study at 31 investigative sites in the United States, Australia, Italy, Netherlands, France and Belgium from 07 August 2012 to 02 August 2016. |
|---|---|
| Pre-assignment Detail | In Part 1, a total of 16 participants were enrolled and treated in the study. A total of 225 participants were screened for entry into Part 2 of the study. Of these 225 participants, 46 were screen failures and 209 were randomized into the study, of which 207 participants were treated. |
| Arm/Group Title | Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel | Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel | Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: Placebo + Gemcitabine/Docetaxel |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received MORAb-004 4 milligram per kilogram (mg/kg), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 milligram per square meter (mg/m^2), infusion, intravenously on Days 1 and 8 and docetaxel, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received MORAb-004 6 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received MORAb-004 8 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received normal saline (0.9 percent [%] sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. |
| Period Title: Part 1 | |||||
| STARTED | 3 | 4 | 9 | 0 | 0 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 3 | 4 | 9 | 0 | 0 |
| Period Title: Part 1 | |||||
| STARTED | 0 | 0 | 0 | 139 | 70 |
| Treated Participants | 0 | 0 | 0 | 140 | 67 |
| COMPLETED | 0 | 0 | 0 | 2 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 137 | 70 |
Baseline Characteristics
| Arm/Group Title | Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel | Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel | Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: Placebo + Gemcitabine/Docetaxel | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received MORAb-004 4 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received MORAb-004 6 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received MORAb-004 8 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Total of all reporting groups |
| Overall Participants | 3 | 4 | 9 | 139 | 70 | 225 |
| Age (Count of Participants) | ||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
3
100%
|
3
75%
|
8
88.9%
|
103
74.1%
|
49
70%
|
166
73.8%
|
| >=65 years |
0
0%
|
1
25%
|
1
11.1%
|
36
25.9%
|
21
30%
|
59
26.2%
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
2
66.7%
|
2
50%
|
3
33.3%
|
63
45.3%
|
32
45.7%
|
102
45.3%
|
| Male |
1
33.3%
|
2
50%
|
6
66.7%
|
76
54.7%
|
38
54.3%
|
123
54.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
1
33.3%
|
0
0%
|
2
22.2%
|
18
12.9%
|
8
11.4%
|
29
12.9%
|
| Not Hispanic or Latino |
2
66.7%
|
4
100%
|
7
77.8%
|
119
85.6%
|
61
87.1%
|
193
85.8%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
2
1.4%
|
1
1.4%
|
3
1.3%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||||
| White |
1
33.3%
|
3
75%
|
8
88.9%
|
116
83.5%
|
57
81.4%
|
185
82.2%
|
| Black or African American |
1
33.3%
|
1
25%
|
0
0%
|
12
8.6%
|
9
12.9%
|
23
10.2%
|
| Asian |
1
33.3%
|
0
0%
|
1
11.1%
|
7
5%
|
2
2.9%
|
11
4.9%
|
| Chinese |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
2.9%
|
2
0.9%
|
| American Indian or Alaskan Native |
0
0%
|
0
0%
|
0
0%
|
1
0.7%
|
0
0%
|
1
0.4%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
3
2.2%
|
0
0%
|
3
1.3%
|
Outcome Measures
| Title | Part 2: Radiologic Progression-free Survival (PFS) |
|---|---|
| Description | PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause. |
| Time Frame | From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT population consisted of all randomized participants and were analyzed according to the treatment assigned by the IxRS. |
| Arm/Group Title | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: Placebo + Gemcitabine/Docetaxel |
|---|---|---|
| Arm/Group Description | Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. |
| Measure Participants | 139 | 70 |
| Median (95% Confidence Interval) [weeks] |
18.7
|
24.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel, Part 2: Placebo + Gemcitabine/Docetaxel |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 0.6562 |
| Comments | ||
| Method | Log Rank | |
| Comments | Two-sided log-rank test | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.08 | |
| Confidence Interval |
(2-Sided) 95% 0.77 to 1.50 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Based on Cox PH model | |
| Title | Part 2: Symptomatic Progression-free Survival |
|---|---|
| Description | PFS including symptomatic progression was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression according to RECIST 1.1, symptomatic progression, or death due to any cause. |
| Time Frame | From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS. |
| Arm/Group Title | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: Placebo + Gemcitabine/Docetaxel |
|---|---|---|
| Arm/Group Description | Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. |
| Measure Participants | 139 | 70 |
| Median (95% Confidence Interval) [weeks] |
18.1
|
24.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel, Part 2: Placebo + Gemcitabine/Docetaxel |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.4469 |
| Comments | ||
| Method | Log Rank | |
| Comments | Two-sided log-rank test | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.13 | |
| Confidence Interval |
(2-Sided) 95% 0.82 to 1.57 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Based on Cox PH model | |
| Title | Part 2: Overall Survival (OS) |
|---|---|
| Description | OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause. |
| Time Frame | From date of first dose until date of death from any cause (up to approximately 3.5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS. |
| Arm/Group Title | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: Placebo + Gemcitabine/Docetaxel |
|---|---|---|
| Arm/Group Description | Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. |
| Measure Participants | 139 | 70 |
| Median (95% Confidence Interval) [months] |
18.3
|
21.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel, Part 2: Placebo + Gemcitabine/Docetaxel |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3153 |
| Comments | ||
| Method | Log Rank | |
| Comments | Two-sided log-rank test | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.23 | |
| Confidence Interval |
(2-Sided) 95% 0.82 to 1.83 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Based on Cox PH model | |
| Title | Part 2: Overall Response Rate (ORR) |
|---|---|
| Description | ORR was defined as the percentage of subjects with either a complete response (CR) or a partial response (PR) based on RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Time Frame | From date of first dose until disease progression (up to approximately 3.5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS. |
| Arm/Group Title | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: Placebo + Gemcitabine/Docetaxel |
|---|---|---|
| Arm/Group Description | Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. |
| Measure Participants | 139 | 70 |
| Number [percentage of participants] |
19.4
646.7%
|
20.0
500%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel, Part 2: Placebo + Gemcitabine/Docetaxel |
|---|---|---|
| Comments | Difference equal to (=) (MORAb 8.0 mg/kg + Gemcitabine/Docetaxel) minus (Placebo + Gemcitabine/Docetaxel). Confidence interval based on a normal approximation to the binomial distribution. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | = 1.000 |
| Comments | ||
| Method | Log Rank | |
| Comments | Two-sided log-rank test | |
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | -0.6 | |
| Confidence Interval |
(2-Sided) 95% -12.0 to 10.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Based on Cox PH model | |
| Title | Part 2: Radiologic Progression-free Survival Rate (PFR) |
|---|---|
| Description | Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points. |
| Time Frame | Weeks 12, 24, 48 and 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS. |
| Arm/Group Title | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: Placebo + Gemcitabine/Docetaxel |
|---|---|---|
| Arm/Group Description | Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. |
| Measure Participants | 139 | 70 |
| 12 weeks |
57.6
1920%
|
61.8
1545%
|
| 24 weeks |
43.3
1443.3%
|
51.0
1275%
|
| 48 weeks |
24.5
816.7%
|
25.2
630%
|
| 52 weeks |
20.8
693.3%
|
21.4
535%
|
| Title | Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels |
|---|---|
| Description | |
| Time Frame | Up to approximately 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS. |
| Arm/Group Title | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: Placebo + Gemcitabine/Docetaxel |
|---|---|---|
| Arm/Group Description | Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. |
| Measure Participants | 139 | 70 |
| Number [participants] |
0
0%
|
0
0%
|
Adverse Events
| Time Frame | From date of first dose until 45 days after last dose of study drug (approximately up to 4 years) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel | Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel | Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: Placebo + Gemcitabine/Docetaxel | |||||
| Arm/Group Description | Participants received MORAb-004 4 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received MORAb-004 6 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received MORAb-004 8 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | |||||
All Cause Mortality |
||||||||||
| Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel | Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel | Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: Placebo + Gemcitabine/Docetaxel | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 1/4 (25%) | 8/9 (88.9%) | 76/140 (54.3%) | 35/67 (52.2%) | |||||
Serious Adverse Events |
||||||||||
| Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel | Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel | Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: Placebo + Gemcitabine/Docetaxel | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 1/4 (25%) | 6/9 (66.7%) | 106/140 (75.7%) | 45/67 (67.2%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 5/140 (3.6%) | 4/67 (6%) | |||||
| Disseminated intravascular coagulation | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 1/67 (1.5%) | |||||
| Febrile neutropenia | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 3/140 (2.1%) | 2/67 (3%) | |||||
| Haemolytic uraemic syndrome | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Leukocytosis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Leukopenia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Neutropenia | 0/3 (0%) | 1/4 (25%) | 1/9 (11.1%) | 2/140 (1.4%) | 2/67 (3%) | |||||
| Thrombocytopenia | 0/3 (0%) | 0/4 (0%) | 3/9 (33.3%) | 2/140 (1.4%) | 3/67 (4.5%) | |||||
| Cardiac disorders | ||||||||||
| Atrial flutter | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Atrial thrombosis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Cardiac arrest | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Cardiac failure | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 1/67 (1.5%) | |||||
| Diastolic dysfunction | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Pericardial effusion | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 2/140 (1.4%) | 0/67 (0%) | |||||
| Sinus tachycardia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal hernia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Abdominal pain | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 2/67 (3%) | |||||
| Colitis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 2/67 (3%) | |||||
| Constipation | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 1/67 (1.5%) | |||||
| Gastrointestinal pain | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Ileus | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 1/67 (1.5%) | |||||
| Intussusception | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 1/67 (1.5%) | |||||
| Nausea | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 4/140 (2.9%) | 1/67 (1.5%) | |||||
| Oesophagitis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 2/140 (1.4%) | 0/67 (0%) | |||||
| Pancreatic cyst | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Upper gastrointestinal haemorrhage | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 1/67 (1.5%) | |||||
| Vomiting | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 3/140 (2.1%) | 0/67 (0%) | |||||
| General disorders | ||||||||||
| Chills | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 1/67 (1.5%) | |||||
| Generalised oedema | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Infusion site extravasation | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Mucosal inflammation | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Non-cardiac chest pain | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Oedema peripheral | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 1/67 (1.5%) | |||||
| Pyrexia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 7/140 (5%) | 2/67 (3%) | |||||
| Systemic inflammatory response syndrome | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 2/140 (1.4%) | 0/67 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Hepatic failure | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Hepatotoxicity | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Portal vein thrombosis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 1/67 (1.5%) | |||||
| Immune system disorders | ||||||||||
| Cytokine release syndrome | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Hypersensitivity | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Infections and infestations | ||||||||||
| Campylobacter gastroenteritis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Cellulitis | 0/3 (0%) | 1/4 (25%) | 1/9 (11.1%) | 8/140 (5.7%) | 3/67 (4.5%) | |||||
| Corona virus infection | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Enterocolitis infectious | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Escherichia sepsis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Influenza | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Liver abscess | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Lobar pneumonia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 2/67 (3%) | |||||
| Lung infection | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 3/140 (2.1%) | 0/67 (0%) | |||||
| Neutropenic sepsis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Pneumocystis jiroveci infection | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 1/67 (1.5%) | |||||
| Pneumocystis jiroveci pneumonia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 1/67 (1.5%) | |||||
| Pneumonia | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 7/140 (5%) | 6/67 (9%) | |||||
| Pneumonia primary atypical | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 1/67 (1.5%) | |||||
| Respiratory tract infection | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Sepsis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 2/140 (1.4%) | 1/67 (1.5%) | |||||
| Soft tissue infection | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Upper respiratory tract infection | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Urinary tract infection | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 3/140 (2.1%) | 0/67 (0%) | |||||
| Wound infection | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Accidental overdose | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Clavicle fracture | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Femur fracture | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Hip fracture | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Infusion related reaction | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Rib fracture | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Investigations | ||||||||||
| Blood creatine phosphokinase increased | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Blood creatinine increased | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 1/67 (1.5%) | |||||
| Neutrophil count decreased | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 1/67 (1.5%) | |||||
| Platelet count decreased | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 3/67 (4.5%) | |||||
| White blood cell count decreased | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 2/140 (1.4%) | 1/67 (1.5%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Dehydration | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 6/140 (4.3%) | 0/67 (0%) | |||||
| Hypoglycaemia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Hypophosphataemia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 1/67 (1.5%) | |||||
| Hypovolaemia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 1/67 (1.5%) | |||||
| Back pain | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 3/67 (4.5%) | |||||
| Groin pain | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Musculoskeletal chest pain | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Myalgia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Myositis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Pain in extremity | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 2/140 (1.4%) | 0/67 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Cancer pain | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Malignant pleural effusion | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Metastases to central nervous system | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 1/67 (1.5%) | |||||
| Tumour pain | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Nervous system disorders | ||||||||||
| Depressed level of consciousness | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Embolic stroke | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 1/67 (1.5%) | |||||
| Encephalopathy | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Lethargy | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Memory impairment | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Peripheral motor neuropathy | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 1/67 (1.5%) | |||||
| Presyncope | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Syncope | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 2/140 (1.4%) | 0/67 (0%) | |||||
| Transient global amnesia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Confusional state | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Mental status changes | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 1/67 (1.5%) | |||||
| Renal and urinary disorders | ||||||||||
| Haematuria | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Hydronephrosis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Renal failure | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Renal failure acute | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 2/140 (1.4%) | 0/67 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Dyspnoea | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 6/140 (4.3%) | 3/67 (4.5%) | |||||
| Haemoptysis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 2/140 (1.4%) | 1/67 (1.5%) | |||||
| Haemothorax | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Hypoxia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Pleural effusion | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 3/140 (2.1%) | 0/67 (0%) | |||||
| Pleural haemorrhage | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 1/67 (1.5%) | |||||
| Pneumonitis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 2/140 (1.4%) | 2/67 (3%) | |||||
| Pneumothorax | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 4/140 (2.9%) | 0/67 (0%) | |||||
| Pulmonary embolism | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 2/140 (1.4%) | 1/67 (1.5%) | |||||
| Pulmonary haemorrhage | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Pulmonary oedema | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 3/140 (2.1%) | 0/67 (0%) | |||||
| Respiratory failure | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 1/67 (1.5%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Rash | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 1/67 (1.5%) | |||||
| Vascular disorders | ||||||||||
| Capillary leak syndrome | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Deep vein thrombosis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 2/140 (1.4%) | 0/67 (0%) | |||||
| Hypertension | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Hypotension | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
| Vena cava thrombosis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 1/140 (0.7%) | 0/67 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel | Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel | Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Part 2: Placebo + Gemcitabine/Docetaxel | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 4/4 (100%) | 9/9 (100%) | 140/140 (100%) | 66/67 (98.5%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 2/3 (66.7%) | 1/4 (25%) | 8/9 (88.9%) | 85/140 (60.7%) | 37/67 (55.2%) | |||||
| Thrombocytopenia | 3/3 (100%) | 0/4 (0%) | 8/9 (88.9%) | 56/140 (40%) | 28/67 (41.8%) | |||||
| Neutropenia | 1/3 (33.3%) | 2/4 (50%) | 4/9 (44.4%) | 32/140 (22.9%) | 15/67 (22.4%) | |||||
| Leukopenia | 1/3 (33.3%) | 0/4 (0%) | 0/9 (0%) | 20/140 (14.3%) | 11/67 (16.4%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Deafness Unilateral | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Ear Pain | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Tinnitus | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Eye disorders | ||||||||||
| Lacrimation Increased | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 8/140 (5.7%) | 6/67 (9%) | |||||
| Conjunctivitis | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Dry Eye | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Vision Blurred | 1/3 (33.3%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 0/67 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Nausea | 2/3 (66.7%) | 1/4 (25%) | 5/9 (55.6%) | 75/140 (53.6%) | 34/67 (50.7%) | |||||
| Constipation | 2/3 (66.7%) | 1/4 (25%) | 2/9 (22.2%) | 54/140 (38.6%) | 25/67 (37.3%) | |||||
| Abdominal pain | 1/3 (33.3%) | 2/4 (50%) | 1/9 (11.1%) | 11/140 (7.9%) | 15/67 (22.4%) | |||||
| Diarrhoea | 1/3 (33.3%) | 0/4 (0%) | 2/9 (22.2%) | 61/140 (43.6%) | 24/67 (35.8%) | |||||
| Vomiting | 1/3 (33.3%) | 2/4 (50%) | 0/9 (0%) | 38/140 (27.1%) | 11/67 (16.4%) | |||||
| Stomatitis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 17/140 (12.1%) | 5/67 (7.5%) | |||||
| Dyspepsia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 10/140 (7.1%) | 2/67 (3%) | |||||
| Abdominal Pain Upper | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 9/140 (6.4%) | 6/67 (9%) | |||||
| Dry Mouth | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 8/140 (5.7%) | 5/67 (7.5%) | |||||
| Gastrooesophageal Reflux Disease | 1/3 (33.3%) | 1/4 (25%) | 0/9 (0%) | 8/140 (5.7%) | 4/67 (6%) | |||||
| Dental Caries | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Flatulence | 1/3 (33.3%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 0/67 (0%) | |||||
| Frequent Bowel Movements | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 0/140 (0%) | 0/67 (0%) | |||||
| Peptic Ulcer | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| General disorders | ||||||||||
| Fatigue | 3/3 (100%) | 3/4 (75%) | 6/9 (66.7%) | 103/140 (73.6%) | 44/67 (65.7%) | |||||
| Oedema peripheral | 1/3 (33.3%) | 2/4 (50%) | 2/9 (22.2%) | 59/140 (42.1%) | 29/67 (43.3%) | |||||
| Pyrexia | 2/3 (66.7%) | 1/4 (25%) | 4/9 (44.4%) | 51/140 (36.4%) | 17/67 (25.4%) | |||||
| Chills | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 28/140 (20%) | 3/67 (4.5%) | |||||
| Influenza Like Illness | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 15/140 (10.7%) | 2/67 (3%) | |||||
| Mucosal Inflammation | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 12/140 (8.6%) | 6/67 (9%) | |||||
| Pain | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 11/140 (7.9%) | 4/67 (6%) | |||||
| Asthenia | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 7/140 (5%) | 4/67 (6%) | |||||
| Chest Pain | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 7/140 (5%) | 2/67 (3%) | |||||
| Non-Cardiac Chest Pain | 0/3 (0%) | 0/4 (0%) | 2/9 (22.2%) | 7/140 (5%) | 1/67 (1.5%) | |||||
| Catheter Site Rash | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 0/140 (0%) | 0/67 (0%) | |||||
| Early Satiety | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 0/140 (0%) | 0/67 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Hyperbilirubinaemia | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Infections and infestations | ||||||||||
| Upper Respiratory Tract Infection | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 17/140 (12.1%) | 3/67 (4.5%) | |||||
| Urinary Tract Infection | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 13/140 (9.3%) | 4/67 (6%) | |||||
| Cellulitis | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 9/140 (6.4%) | 4/67 (6%) | |||||
| Nasopharyngitis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 7/140 (5%) | 3/67 (4.5%) | |||||
| Pneumonia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 7/140 (5%) | 2/67 (3%) | |||||
| Sinusitis | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 7/140 (5%) | 2/67 (3%) | |||||
| Diverticulitis | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 0/140 (0%) | 0/67 (0%) | |||||
| Gastrointestinal Viral Infection | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Lower Respiratory Tract Infection Viral | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 0/140 (0%) | 0/67 (0%) | |||||
| Oral Candidiasis | 0/3 (0%) | 0/4 (0%) | 2/9 (22.2%) | 0/140 (0%) | 0/67 (0%) | |||||
| Staphylococcal Skin Infection | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Viral Upper Respiratory Tract Infection | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Infusion Related Reaction | 1/3 (33.3%) | 0/4 (0%) | 0/9 (0%) | 10/140 (7.1%) | 1/67 (1.5%) | |||||
| Contusion | 0/3 (0%) | 2/4 (50%) | 0/9 (0%) | 0/140 (0%) | 0/67 (0%) | |||||
| Tooth Fracture | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Investigations | ||||||||||
| Alanine Aminotransferase Increased | 0/3 (0%) | 0/4 (0%) | 3/9 (33.3%) | 31/140 (22.1%) | 12/67 (17.9%) | |||||
| Platelet Count Decreased | 1/3 (33.3%) | 0/4 (0%) | 0/9 (0%) | 20/140 (14.3%) | 15/67 (22.4%) | |||||
| Aspartate Aminotransferase Increased | 0/3 (0%) | 0/4 (0%) | 2/9 (22.2%) | 16/140 (11.4%) | 8/67 (11.9%) | |||||
| Blood Alkaline Phosphatase Increased | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 13/140 (9.3%) | 7/67 (10.4%) | |||||
| Neutrophil Count Decreased | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 13/140 (9.3%) | 9/67 (13.4%) | |||||
| White Blood Cell Count Decreased | 1/3 (33.3%) | 0/4 (0%) | 0/9 (0%) | 11/140 (7.9%) | 10/67 (14.9%) | |||||
| Blood Creatinine Increased | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 10/140 (7.1%) | 4/67 (6%) | |||||
| Blood Albumin Decreased | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 8/140 (5.7%) | 4/67 (6%) | |||||
| Lymphocyte Count Decreased | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 8/140 (5.7%) | 8/67 (11.9%) | |||||
| Weight Decreased | 0/3 (0%) | 0/4 (0%) | 2/9 (22.2%) | 8/140 (5.7%) | 2/67 (3%) | |||||
| Blood Calcium Decreased | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 7/140 (5%) | 2/67 (3%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Decreased appetite | 2/3 (66.7%) | 0/4 (0%) | 2/9 (22.2%) | 43/140 (30.7%) | 16/67 (23.9%) | |||||
| Hypokalaemia | 0/3 (0%) | 0/4 (0%) | 3/9 (33.3%) | 19/140 (13.6%) | 7/67 (10.4%) | |||||
| Hyperglycaemia | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 22/140 (15.7%) | 4/67 (6%) | |||||
| Dehydration | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 12/140 (8.6%) | 4/67 (6%) | |||||
| Hypoalbuminaemia | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 10/140 (7.1%) | 2/67 (3%) | |||||
| Hypomagnesaemia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 8/140 (5.7%) | 2/67 (3%) | |||||
| Hyponatraemia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 8/140 (5.7%) | 1/67 (1.5%) | |||||
| Hypocalcaemia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 7/140 (5%) | 5/67 (7.5%) | |||||
| Increased Appetite | 1/3 (33.3%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 0/67 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Back pain | 1/3 (33.3%) | 3/4 (75%) | 1/9 (11.1%) | 21/140 (15%) | 13/67 (19.4%) | |||||
| Pain in extremity | 1/3 (33.3%) | 2/4 (50%) | 1/9 (11.1%) | 25/140 (17.9%) | 13/67 (19.4%) | |||||
| Arthralgia | 0/3 (0%) | 3/4 (75%) | 0/9 (0%) | 21/140 (15%) | 15/67 (22.4%) | |||||
| Myalgia | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 34/140 (24.3%) | 13/67 (19.4%) | |||||
| Bone Pain | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 20/140 (14.3%) | 10/67 (14.9%) | |||||
| Musculoskeletal Pain | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 14/140 (10%) | 5/67 (7.5%) | |||||
| Musculoskeletal Chest Pain | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 8/140 (5.7%) | 2/67 (3%) | |||||
| Groin Pain | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Metatarsalgia | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Muscle Twitching | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Musculoskeletal Stiffness | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Pain In Jaw | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Tumour Pain | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 0/140 (0%) | 0/67 (0%) | |||||
| Nervous system disorders | ||||||||||
| Headache | 1/3 (33.3%) | 2/4 (50%) | 3/9 (33.3%) | 57/140 (40.7%) | 13/67 (19.4%) | |||||
| Dysgeusia | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 31/140 (22.1%) | 15/67 (22.4%) | |||||
| Dizziness | 0/3 (0%) | 1/4 (25%) | 1/9 (11.1%) | 16/140 (11.4%) | 10/67 (14.9%) | |||||
| Neuropathy Peripheral | 0/3 (0%) | 1/4 (25%) | 1/9 (11.1%) | 16/140 (11.4%) | 16/67 (23.9%) | |||||
| Paraesthesia | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 14/140 (10%) | 7/67 (10.4%) | |||||
| Peripheral Sensory Neuropathy | 1/3 (33.3%) | 0/4 (0%) | 0/9 (0%) | 8/140 (5.7%) | 5/67 (7.5%) | |||||
| Hyperaesthesia | 1/3 (33.3%) | 1/4 (25%) | 0/9 (0%) | 0/140 (0%) | 0/67 (0%) | |||||
| Loss Of Consciousness | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Neuralgia | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Insomnia | 1/3 (33.3%) | 0/4 (0%) | 1/9 (11.1%) | 24/140 (17.1%) | 12/67 (17.9%) | |||||
| Anxiety | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 7/140 (5%) | 2/67 (3%) | |||||
| Depression | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 7/140 (5%) | 2/67 (3%) | |||||
| Renal and urinary disorders | ||||||||||
| Dysuria | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Urinary Tract Obstruction | 1/3 (33.3%) | 0/4 (0%) | 0/9 (0%) | 0/140 (0%) | 0/67 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Cough | 0/3 (0%) | 0/4 (0%) | 2/9 (22.2%) | 42/140 (30%) | 23/67 (34.3%) | |||||
| Dyspnoea | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 41/140 (29.3%) | 18/67 (26.9%) | |||||
| Epistaxis | 0/3 (0%) | 1/4 (25%) | 2/9 (22.2%) | 18/140 (12.9%) | 10/67 (14.9%) | |||||
| Dyspnoea Exertional | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 12/140 (8.6%) | 7/67 (10.4%) | |||||
| Oropharyngeal pain | 1/3 (33.3%) | 0/4 (0%) | 2/9 (22.2%) | 11/140 (7.9%) | 5/67 (7.5%) | |||||
| Pleural Effusion | 0/3 (0%) | 0/4 (0%) | 2/9 (22.2%) | 10/140 (7.1%) | 3/67 (4.5%) | |||||
| Haemoptysis | 0/3 (0%) | 0/4 (0%) | 2/9 (22.2%) | 0/140 (0%) | 0/67 (0%) | |||||
| Hiccups | 1/3 (33.3%) | 1/4 (25%) | 0/9 (0%) | 0/140 (0%) | 0/67 (0%) | |||||
| Hypoxia | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Nasal Congestion | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Oropharyngeal Discomfort | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Rhinitis Allergic | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Wheezing | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Alopecia | 2/3 (66.7%) | 0/4 (0%) | 2/9 (22.2%) | 48/140 (34.3%) | 21/67 (31.3%) | |||||
| Rash | 0/3 (0%) | 1/4 (25%) | 1/9 (11.1%) | 30/140 (21.4%) | 23/67 (34.3%) | |||||
| Pruritus | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 20/140 (14.3%) | 3/67 (4.5%) | |||||
| Rash Maculo-Papular | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 12/140 (8.6%) | 1/67 (1.5%) | |||||
| Dry Skin | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 10/140 (7.1%) | 5/67 (7.5%) | |||||
| Erythema | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 10/140 (7.1%) | 4/67 (6%) | |||||
| Hyperhidrosis | 1/3 (33.3%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Nail Disorder | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Night Sweats | 0/3 (0%) | 1/4 (25%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Rash Pruritic | 0/3 (0%) | 0/4 (0%) | 1/9 (11.1%) | 0/140 (0%) | 0/67 (0%) | |||||
| Skin Exfoliation | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 0/140 (0%) | 0/67 (0%) | |||||
| Vascular disorders | ||||||||||
| Hypertension | 0/3 (0%) | 0/4 (0%) | 0/9 (0%) | 17/140 (12.1%) | 2/67 (3%) | |||||
| Hot Flush | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 9/140 (6.4%) | 0/67 (0%) | |||||
| Flushing | 1/3 (33.3%) | 0/4 (0%) | 1/9 (11.1%) | 7/140 (5%) | 4/67 (6%) | |||||
| Hypotension | 0/3 (0%) | 1/4 (25%) | 0/9 (0%) | 7/140 (5%) | 7/67 (10.4%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Eisai Medical Information |
|---|---|
| Organization | Eisai Inc. |
| Phone | 1-888-274-2378 |
| esi_oncmedinfo@eisai.com |
Responsible Party:
Morphotek
ClinicalTrials.gov Identifier:
NCT01574716
Other Study ID Numbers:
- MORAb-004-203-STS
- 2012-001399-12
First Posted:
Apr 10, 2012
Last Update Posted:
Aug 21, 2019
Last Verified:
Nov 1, 2016