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Trial record 1 of 1 for:    NCT02357147
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Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM) (ARTEMIS)

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ClinicalTrials.gov Identifier: NCT02357147
Recruitment Status : Terminated (Due to business reasons)
First Posted : February 6, 2015
Results First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Morphotek

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Mesothelioma, Malignant
Interventions Drug: Placebo
Drug: Amatuximab
Drug: Pemetrexed
Drug: Cisplatin
Enrollment 124
Recruitment Details Participants took part in the study at 36 investigative sites in the United States, France, Germany, Italy, the United Kingdom, and Australia from 03 November 2015 to 30 November 2018.
Pre-assignment Details A total of 124 participants were enrolled (signed informed consent form), of which, 16 were screen failures, 108 were randomized, and 106 were treated. Deaths that were primary cause of treatment discontinuation are reported in participant flow excluding those that occurred after treatment discontinuation.
Arm/Group Title Amatuximab + Pemetrexed + Cisplatin Placebo + Pemetrexed + Cisplatin
Hide Arm/Group Description During Combination Treatment Phase, participants received amatuximab 5 milligram per kilogram (mg/kg), infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 milligram per square meter (mg/m^2) and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression. During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
Period Title: Combination Treatment Phase
Started 52 56
Treated 52 54
Completed 26 29
Not Completed 26 27
Reason Not Completed
Progressive Disease (Radiographic test)             3             3
Progressive Disease(Clinical assessment)             0             1
Investigator Discretion             1             1
Withdrawal by Subject             4             2
Test Article Held (Greater than 21 Days)             4             1
Adverse Event             12             4
Death             1             1
Sponsor Decision             0             12
Other             1             0
Not treated             0             2
Period Title: Maintenance Treatment Phase
Started 26 29
Treated 25 29
Completed 0 0
Not Completed 26 29
Reason Not Completed
Progressive Disease (Radiographic test)             15             10
Withdrawal by Subject             0             1
Test Article Held (Greater than 21 Days)             10             0
Adverse Event             0             3
Sponsor Decision             0             15
Not Treated             1             0
Arm/Group Title Amatuximab + Pemetrexed + Cisplatin Placebo + Pemetrexed + Cisplatin Total
Hide Arm/Group Description During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression. During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression. Total of all reporting groups
Overall Number of Baseline Participants 52 54 106
Hide Baseline Analysis Population Description
The safety analysis set was defined as all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 54 participants 106 participants
67.9  (6.08) 66.9  (7.96) 67.4  (7.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 54 participants 106 participants
Female
15
  28.8%
14
  25.9%
29
  27.4%
Male
37
  71.2%
40
  74.1%
77
  72.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 54 participants 106 participants
Hispanic or Latino
1
   1.9%
7
  13.0%
8
   7.5%
Not Hispanic or Latino
42
  80.8%
37
  68.5%
79
  74.5%
Unknown or Not Reported
9
  17.3%
10
  18.5%
19
  17.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 54 participants 106 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.9%
0
   0.0%
1
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   1.9%
1
   0.9%
White
45
  86.5%
46
  85.2%
91
  85.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
  11.5%
7
  13.0%
13
  12.3%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description AEs included both non-SAEs and SAEs and the same participant can have both SAEs and as well non-SAEs.
Time Frame Baseline up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was defined as all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin Maintenance Treatment Phase: Amatuximab Maintenance Treatment Phase: Placebo
Hide Arm/Group Description:
During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
Overall Number of Participants Analyzed 52 54 25 29
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
50
  96.2%
52
  96.3%
19
  76.0%
21
  72.4%
SAEs
15
  28.8%
11
  20.4%
1
   4.0%
4
  13.8%
Time Frame From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Adverse Event Reporting Description Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
 
Arm/Group Title Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin Maintenance Treatment Phase: Amatuximab Maintenance Treatment Phase: Placebo
Hide Arm/Group Description During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
All-Cause Mortality
Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin Maintenance Treatment Phase: Amatuximab Maintenance Treatment Phase: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/52 (11.54%)      3/54 (5.56%)      2/25 (8.00%)      1/29 (3.45%)    
Hide Serious Adverse Events
Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin Maintenance Treatment Phase: Amatuximab Maintenance Treatment Phase: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/52 (28.85%)      11/54 (20.37%)      1/25 (4.00%)      4/29 (13.79%)    
Blood and lymphatic system disorders         
Anaemia  1  0/52 (0.00%)  0 0/54 (0.00%)  0 0/25 (0.00%)  0 1/29 (3.45%)  2
Neutropenia  1  0/52 (0.00%)  0 2/54 (3.70%)  2 0/25 (0.00%)  0 0/29 (0.00%)  0
Pancytopenia  1  1/52 (1.92%)  1 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
Cardiac disorders         
Atrial fibrillation  1  0/52 (0.00%)  0 1/54 (1.85%)  2 0/25 (0.00%)  0 0/29 (0.00%)  0
Ear and labyrinth disorders         
Vertigo  1  0/52 (0.00%)  0 1/54 (1.85%)  1 0/25 (0.00%)  0 0/29 (0.00%)  0
Eye disorders         
Amaurosis  1  0/52 (0.00%)  0 0/54 (0.00%)  0 1/25 (4.00%)  1 0/29 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain  1  1/52 (1.92%)  1 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
Colitis  1  1/52 (1.92%)  1 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
Diarrhoea  1  2/52 (3.85%)  2 1/54 (1.85%)  1 0/25 (0.00%)  0 0/29 (0.00%)  0
Dysphagia  1  1/52 (1.92%)  1 0/54 (0.00%)  0 0/25 (0.00%)  0 1/29 (3.45%)  1
Nausea  1  3/52 (5.77%)  3 2/54 (3.70%)  2 0/25 (0.00%)  0 0/29 (0.00%)  0
Vomiting  1  0/52 (0.00%)  0 2/54 (3.70%)  2 0/25 (0.00%)  0 0/29 (0.00%)  0
General disorders         
Chills  1  1/52 (1.92%)  1 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
Fatigue  1  1/52 (1.92%)  1 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
General physical health deterioration  1  1/52 (1.92%)  1 1/54 (1.85%)  1 0/25 (0.00%)  0 0/29 (0.00%)  0
Non-cardiac chest pain  1  0/52 (0.00%)  0 1/54 (1.85%)  1 0/25 (0.00%)  0 0/29 (0.00%)  0
Pyrexia  1  1/52 (1.92%)  1 1/54 (1.85%)  1 0/25 (0.00%)  0 0/29 (0.00%)  0
Immune system disorders         
Anaphylactic reaction  1  1/52 (1.92%)  1 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
Infections and infestations         
Cellulitis  1  1/52 (1.92%)  1 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
Lower respiratory tract infection  1  2/52 (3.85%)  2 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
Lung infection  1  0/52 (0.00%)  0 1/54 (1.85%)  1 0/25 (0.00%)  0 0/29 (0.00%)  0
Mucosal infection  1  1/52 (1.92%)  1 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
Peritonitis  1  0/52 (0.00%)  0 0/54 (0.00%)  0 0/25 (0.00%)  0 1/29 (3.45%)  1
Urinary tract infection  1  2/52 (3.85%)  2 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
Injury, poisoning and procedural complications         
Infusion related reaction  1  2/52 (3.85%)  2 1/54 (1.85%)  1 0/25 (0.00%)  0 0/29 (0.00%)  0
Metabolism and nutrition disorders         
Hypokalaemia  1  1/52 (1.92%)  1 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Musculoskeletal pain  1  1/52 (1.92%)  1 1/54 (1.85%)  1 0/25 (0.00%)  0 0/29 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Cancer pain  1  1/52 (1.92%)  1 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
Nervous system disorders         
Syncope  1  0/52 (0.00%)  0 1/54 (1.85%)  2 0/25 (0.00%)  0 0/29 (0.00%)  0
Psychiatric disorders         
Organic brain syndrome  1  0/52 (0.00%)  0 0/54 (0.00%)  0 0/25 (0.00%)  0 1/29 (3.45%)  1
Renal and urinary disorders         
Acute kidney injury  1  1/52 (1.92%)  1 2/54 (3.70%)  2 0/25 (0.00%)  0 1/29 (3.45%)  1
Renal failure  1  1/52 (1.92%)  1 1/54 (1.85%)  1 0/25 (0.00%)  0 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  0/52 (0.00%)  0 2/54 (3.70%)  2 0/25 (0.00%)  0 0/29 (0.00%)  0
Pulmonary embolism  1  1/52 (1.92%)  1 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
Vascular disorders         
Deep vein thrombosis  1  1/52 (1.92%)  1 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin Maintenance Treatment Phase: Amatuximab Maintenance Treatment Phase: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   50/52 (96.15%)      51/54 (94.44%)      19/25 (76.00%)      21/29 (72.41%)    
Blood and lymphatic system disorders         
Anaemia  1  11/52 (21.15%)  29 12/54 (22.22%)  21 3/25 (12.00%)  11 2/29 (6.90%)  2
Leukopenia  1  3/52 (5.77%)  3 1/54 (1.85%)  1 0/25 (0.00%)  0 0/29 (0.00%)  0
Neutropenia  1  13/52 (25.00%)  35 10/54 (18.52%)  28 2/25 (8.00%)  2 0/29 (0.00%)  0
Thrombocytopenia  1  5/52 (9.62%)  7 1/54 (1.85%)  1 1/25 (4.00%)  1 0/29 (0.00%)  0
Cardiac disorders         
Sinus tachycardia  1  0/52 (0.00%)  0 0/54 (0.00%)  0 0/25 (0.00%)  0 2/29 (6.90%)  2
Ear and labyrinth disorders         
Tinnitus  1  5/52 (9.62%)  6 3/54 (5.56%)  4 0/25 (0.00%)  0 0/29 (0.00%)  0
Eye disorders         
Dry eye  1  3/52 (5.77%)  3 2/54 (3.70%)  2 0/25 (0.00%)  0 0/29 (0.00%)  0
Lacrimation increased  1  4/52 (7.69%)  5 1/54 (1.85%)  1 0/25 (0.00%)  0 1/29 (3.45%)  1
Gastrointestinal disorders         
Abdominal pain  1  3/52 (5.77%)  3 2/54 (3.70%)  4 2/25 (8.00%)  2 0/29 (0.00%)  0
Abdominal pain upper  1  2/52 (3.85%)  5 5/54 (9.26%)  5 1/25 (4.00%)  2 1/29 (3.45%)  1
Constipation  1  17/52 (32.69%)  27 22/54 (40.74%)  32 1/25 (4.00%)  2 2/29 (6.90%)  2
Diarrhoea  1  11/52 (21.15%)  17 10/54 (18.52%)  13 3/25 (12.00%)  3 0/29 (0.00%)  0
Dyspepsia  1  7/52 (13.46%)  8 9/54 (16.67%)  10 1/25 (4.00%)  1 0/29 (0.00%)  0
Nausea  1  34/52 (65.38%)  78 39/54 (72.22%)  83 1/25 (4.00%)  1 3/29 (10.34%)  4
Stomatitis  1  6/52 (11.54%)  7 13/54 (24.07%)  21 0/25 (0.00%)  0 0/29 (0.00%)  0
Vomiting  1  13/52 (25.00%)  25 18/54 (33.33%)  34 2/25 (8.00%)  2 3/29 (10.34%)  5
General disorders         
Asthenia  1  11/52 (21.15%)  18 18/54 (33.33%)  48 1/25 (4.00%)  8 6/29 (20.69%)  9
Chills  1  6/52 (11.54%)  6 1/54 (1.85%)  2 0/25 (0.00%)  0 1/29 (3.45%)  1
Fatigue  1  18/52 (34.62%)  27 19/54 (35.19%)  31 3/25 (12.00%)  3 2/29 (6.90%)  3
Non-cardiac chest pain  1  4/52 (7.69%)  5 3/54 (5.56%)  3 2/25 (8.00%)  2 2/29 (6.90%)  3
Oedema peripheral  1  3/52 (5.77%)  3 3/54 (5.56%)  6 0/25 (0.00%)  0 2/29 (6.90%)  2
Pyrexia  1  7/52 (13.46%)  8 3/54 (5.56%)  5 0/25 (0.00%)  0 1/29 (3.45%)  1
Infections and infestations         
Conjunctivitis  1  4/52 (7.69%)  6 4/54 (7.41%)  7 0/25 (0.00%)  0 0/29 (0.00%)  0
Nasopharyngitis  1  4/52 (7.69%)  4 1/54 (1.85%)  1 3/25 (12.00%)  3 1/29 (3.45%)  1
Influenza  1  0/52 (0.00%)  0 0/54 (0.00%)  0 2/25 (8.00%)  2 0/29 (0.00%)  0
Tooth abscess  1  0/52 (0.00%)  0 0/54 (0.00%)  0 2/25 (8.00%)  2 0/29 (0.00%)  0
Injury, poisoning and procedural complications         
Infusion related reaction  1  6/52 (11.54%)  9 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1  0/52 (0.00%)  0 3/54 (5.56%)  3 0/25 (0.00%)  0 0/29 (0.00%)  0
Blood bilirubin increased  1  0/52 (0.00%)  0 3/54 (5.56%)  3 0/25 (0.00%)  0 0/29 (0.00%)  0
Blood creatinine increased  1  3/52 (5.77%)  5 6/54 (11.11%)  7 0/25 (0.00%)  0 2/29 (6.90%)  2
Metabolism and nutrition disorders         
Decreased appetite  1  14/52 (26.92%)  23 17/54 (31.48%)  25 1/25 (4.00%)  1 2/29 (6.90%)  2
Dehydration  1  3/52 (5.77%)  3 2/54 (3.70%)  2 0/25 (0.00%)  0 0/29 (0.00%)  0
Hypokalaemia  1  3/52 (5.77%)  4 3/54 (5.56%)  3 0/25 (0.00%)  0 0/29 (0.00%)  0
Hypomagnesaemia  1  2/52 (3.85%)  2 3/54 (5.56%)  3 0/25 (0.00%)  0 0/29 (0.00%)  0
Hyponatraemia  1  1/52 (1.92%)  1 3/54 (5.56%)  5 0/25 (0.00%)  0 0/29 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  2/52 (3.85%)  4 5/54 (9.26%)  6 1/25 (4.00%)  1 0/29 (0.00%)  0
Musculoskeletal chest pain  1  2/52 (3.85%)  2 2/54 (3.70%)  2 2/25 (8.00%)  2 1/29 (3.45%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Cancer pain  1  1/52 (1.92%)  1 3/54 (5.56%)  4 0/25 (0.00%)  0 1/29 (3.45%)  1
Nervous system disorders         
Dysgeusia  1  5/52 (9.62%)  5 6/54 (11.11%)  8 0/25 (0.00%)  0 1/29 (3.45%)  1
Headache  1  6/52 (11.54%)  6 4/54 (7.41%)  4 1/25 (4.00%)  1 1/29 (3.45%)  1
Paraesthesia  1  7/52 (13.46%)  9 2/54 (3.70%)  3 3/25 (12.00%)  4 1/29 (3.45%)  1
Peripheral sensory neuropathy  1  2/52 (3.85%)  2 5/54 (9.26%)  9 0/25 (0.00%)  0 4/29 (13.79%)  6
Tremor  1  2/52 (3.85%)  2 3/54 (5.56%)  3 0/25 (0.00%)  0 1/29 (3.45%)  1
Psychiatric disorders         
Anxiety  1  4/52 (7.69%)  4 1/54 (1.85%)  1 0/25 (0.00%)  0 0/29 (0.00%)  0
Insomnia  1  3/52 (5.77%)  3 4/54 (7.41%)  4 0/25 (0.00%)  0 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  8/52 (15.38%)  12 6/54 (11.11%)  6 4/25 (16.00%)  7 5/29 (17.24%)  6
Dyspnoea  1  9/52 (17.31%)  10 3/54 (5.56%)  4 4/25 (16.00%)  7 0/29 (0.00%)  0
Epistaxis  1  4/52 (7.69%)  5 2/54 (3.70%)  2 1/25 (4.00%)  1 0/29 (0.00%)  0
Hiccups  1  1/52 (1.92%)  1 3/54 (5.56%)  3 0/25 (0.00%)  0 0/29 (0.00%)  0
Productive cough  1  4/52 (7.69%)  4 3/54 (5.56%)  3 2/25 (8.00%)  2 2/29 (6.90%)  3
Pulmonary embolism  1  3/52 (5.77%)  3 1/54 (1.85%)  1 0/25 (0.00%)  0 0/29 (0.00%)  0
Dyspnoea exertional  1  1/52 (1.92%)  1 0/54 (0.00%)  0 2/25 (8.00%)  2 0/29 (0.00%)  0
Skin and subcutaneous tissue disorders         
Alopecia  1  1/52 (1.92%)  1 3/54 (5.56%)  3 1/25 (4.00%)  1 1/29 (3.45%)  1
Dry skin  1  2/52 (3.85%)  2 4/54 (7.41%)  4 1/25 (4.00%)  1 1/29 (3.45%)  1
Hyperhidrosis  1  2/52 (3.85%)  2 1/54 (1.85%)  1 1/25 (4.00%)  1 2/29 (6.90%)  2
Pruritus  1  3/52 (5.77%)  3 0/54 (0.00%)  0 0/25 (0.00%)  0 0/29 (0.00%)  0
Rash  1  6/52 (11.54%)  6 7/54 (12.96%)  10 2/25 (8.00%)  2 0/29 (0.00%)  0
Night sweats  1  0/52 (0.00%)  0 1/54 (1.85%)  1 0/25 (0.00%)  0 2/29 (6.90%)  2
Vascular disorders         
Hypertension  1  3/52 (5.77%)  6 0/54 (0.00%)  0 0/25 (0.00%)  0 1/29 (3.45%)  1
Hypotension  1  4/52 (7.69%)  4 0/54 (0.00%)  0 0/25 (0.00%)  0 1/29 (3.45%)  1
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
The study was terminated due to business decision. No safety concerns involved in decision to terminate this study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
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Name/Title: Eisai Medical Information
Organization: Eisai Inc.
Phone: 1-888-274-2378
EMail: esi_oncmedinfo@eisai.com
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Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT02357147    
Other Study ID Numbers: MORAb-009-201
2014-004489-85 ( EudraCT Number )
First Submitted: January 14, 2015
First Posted: February 6, 2015
Results First Submitted: March 4, 2020
Results First Posted: March 17, 2020
Last Update Posted: March 17, 2020