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A Study of IMGN901 for Patients With Advanced Solid Tumors and Extensive Stage Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01237678
Recruitment Status : Terminated (Study was stopped early due to lack of efficacy signal and safety concerns)
First Posted : November 9, 2010
Results First Posted : January 18, 2018
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Small Cell Lung Cancer
Interventions Drug: IMGN901
Drug: Carboplatin and Etoposide
Enrollment 181
Recruitment Details Participants were recruited from, and treated at, 45 study sites in the U.S., Canada, Spain, and the U.K. between November 2010 and May 2015.
Pre-assignment Details Patients were screened during a 28-day period
Arm/Group Title Phase I - IMGN901 + Carboplatin + Etoposide Phase II - IMGN901 + Carboplatin + Etoposide Phase II - Carboplatin + Etoposide
Hide Arm/Group Description Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle.The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease. IMGN901 was administered at the RP2D (recommended phase II dose) determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease. Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
Period Title: Phase I - IMGN901+Carboplatin+Etoposide
Started 33 0 0
Received Intervention 33 0 0
Completed 0 0 0
Not Completed 33 0 0
Reason Not Completed
Adverse Event             5             0             0
Lack of Efficacy             24             0             0
Withdrawal by Subject             3             0             0
Incorrect Original Diagnosis             1             0             0
Period Title: Phase II
Started 0 98 [1] 50 [2]
Received Intervention 0 94 47
Completed 0 0 0
Not Completed 0 98 50
Reason Not Completed
Adverse Event             0             39             9
Death             0             0             2
Lack of Efficacy             0             25             3
Withdrawal by Subject             0             1             5
Completed Cycles 4-6             0             11             21
Sponsor Decision/Study Closed             0             18             7
Randomized but were not treated             0             4             3
[1]
98 subjects were randomized, 94 subjects treated
[2]
50 subjects were randomized, 47 subjects treated
Arm/Group Title Phase I - IMGN901 + Carboplatin + Etoposide Phase II - IMGN901 + Carboplatin + Etoposide Phase II - Carboplatin + Etoposide Total
Hide Arm/Group Description Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle.The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease. IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease. Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated. Total of all reporting groups
Overall Number of Baseline Participants 33 94 47 174
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 94 participants 47 participants 174 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  63.6%
49
  52.1%
26
  55.3%
96
  55.2%
>=65 years
12
  36.4%
45
  47.9%
21
  44.7%
78
  44.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 94 participants 47 participants 174 participants
Female
20
  60.6%
40
  42.6%
22
  46.8%
82
  47.1%
Male
13
  39.4%
54
  57.4%
25
  53.2%
92
  52.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 94 participants 47 participants 174 participants
American Indian or Alaska Native
1
   3.0%
0
   0.0%
0
   0.0%
1
   0.6%
Asian
0
   0.0%
1
   1.1%
0
   0.0%
1
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   6.1%
3
   3.2%
2
   4.3%
7
   4.0%
White
30
  90.9%
90
  95.7%
44
  93.6%
164
  94.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   2.1%
1
   0.6%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 94 participants 47 participants 174 participants
0
14
  42.4%
22
  23.4%
12
  25.5%
48
  27.6%
1
19
  57.6%
62
  66.0%
32
  68.1%
113
  64.9%
2
0
   0.0%
10
  10.6%
3
   6.4%
13
   7.5%
[1]
Measure Description:

0 = Fully active, able to carry out all pre-disease performance without restriction.

  1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
  2. = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about more than 50% of waking hours.
History of Smoking  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 94 participants 47 participants 174 participants
Yes 21 93 46 160
No 12 1 1 14
1.Primary Outcome
Title Occurrence of Dose Limiting Toxicities (DLT)
Hide Description The primary outcome measure for Phase I was to determine the maximum tolerated dose (MTD) and characterize the dose limiting toxicities (DLT) of IMGN901 when administered in combination with carboplatin/etoposide chemotherapy followed by IMGN901 alone in patients with solid tumors. For the purposes of dose escalation and determination of MTD, DLTs were defined as AEs or abnormal laboratory values related to study treatment which occurred in Cycle 1 of the Dose Escalation phase, including any AEs that resulted in failure to meet the criteria for re-treatment. The following events were considered DLTs (using the most current version of CTCAE): febrile neutropenia; Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding; ≥ Grade 3 peripheral neuropathy; ≥ Grade 3 vomiting, nausea, or diarrhea that persisted despite the use of optimal therapy; other ≥ grade 3 non-hematologic toxicity (with the exception of brief fatigue i.e. ≤ 72 hours and alopecia)
Time Frame 21 days (Cycle 1)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
A total of 33 patients were analyzed as part of the Dose escalation phase.
Arm/Group Title IMGN901 60 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2 IMGN901 75 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2 IMGN901 75 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2 IMGN901 90 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2 IMGN901 112 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 6 6 3 6 12
Measure Type: Number
Unit of Measure: participants
Grade 3 febrile neutropenia 0 1 0 0 0
Grade 4 febrile neutropenia 1 1 0 1 0
Grade 4 thrombocytopenia 0 2 0 1 1
Grade 4 granulocytopenia 0 1 0 0 0
Grade 3 lobar pneumonia 0 0 0 0 1
2.Primary Outcome
Title Progression Free Survival (PFS) in Phase II
Hide Description The primary outcome measure for Phase II was to determine the efficacy of IMGN901 in combination with carboplatin/etoposide chemotherapy as first-line treatment for patients with extensive stage small cell lung cancer. PFS was defined as the time from enrollment until objective tumor progression according to RECIST 1.1 or death on study due to any cause, whichever occurred first. Only the results from the experimental arm (IMGN901 + carboplatin + etoposide) are presented as the primary objective of this phase of the study was to compare PFS in the experimental arm (triplet combination) against historical PFS rates for carboplatin and etoposide. The control arm was planned primarily to reliably assess the safety of IMGN901 and to demonstrate whether the or not the historical assumptions regarding efficacy were confirmed.
Time Frame From randomization to objective tumor progression or death (up to post-treatment follow-up 28 days after last dose, up to 22 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
A total of 82 patients from the IMGN901 + carboplatin + etoposide safety population (N=94) were included in the efficacy analyses, due to the lack of post-baseline evaluations for 12 participants.
Arm/Group Title Phase II - IMGN901 + Carboplatin + Etoposide
Hide Arm/Group Description:
IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
Overall Number of Participants Analyzed 82
Median (95% Confidence Interval)
Unit of Measure: months
6.2
(5.4 to 7.2)
3.Primary Outcome
Title Maximum Tolerated Dose (MTD) of IMGN901
Hide Description A primary outcome measure for Phase I was to determine the maximum tolerated dose (MTD) of IMGN901 when administered in combination with carboplatin/etoposide chemotherapy followed by IMGN901 alone in patients with solid tumors. The MTD was determined based on DLTs that occurred during Cycle 1.
Time Frame 21 days (Cycle 1)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
During escalation, carboplatin dosing was reduced from AUC 6 to AUC 5 due to poor tolerability; therefore the MTD for IMGN901 was determined in combination with carboplatin AUC5 and 100 mg/m^2 etoposide
Arm/Group Title Phase I - IMGN901 + Carboplatin + Etoposide
Hide Arm/Group Description:
Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle.The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: mg/m^2
112
4.Secondary Outcome
Title Overview of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description To assess the type and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs). An AE was defined as any noxious, pathologic, or unintended change un anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of the study, whether or not deemed study drug-related. An SAE was any AE resulting in death, life-threatening experience, initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, or congenital defect. All AEs were reported from the time of the first dose of study treatment until 28 days after the final dose of study drug. the severity of AEs were graded by the Investigator using National cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 4.0.
Time Frame From the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment (up to 22 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I - IMGN901 + Carboplatin + Etoposide Phase II - IMGN901 + Carboplatin + Etoposide Phase II - Carboplatin + Etoposide
Hide Arm/Group Description:
Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle.The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
Overall Number of Participants Analyzed 33 94 47
Measure Type: Number
Unit of Measure: participants
Any TEAE 33 94 46
Related TEAE 32 90 39
Any SAE 16 54 23
Related SAE 8 30 9
TEAEs leading to discontinuation 8 50 6
Any Grade ≥ 3 TEAE 29 92 42
Related Grade ≥ 3 TEAE 22 83 33
Deaths within 28 days of last dose 1 14 5
5.Secondary Outcome
Title Progression Free Survival (PFS) Rate at 6 Months
Hide Description The trial was not empowered to permit a statistically informative comparison of the randomized treatment groups with respect to PFS. The activity of IMGN901 was assessed by comparing the PFS rate at 6 months in the IMGN901 experimental arm against the historical 6-month PFS rate of 0.44 (equivalently a median PFS = 5 months). Only the results from the experimental arm (IMGN901 + carboplatin + etoposide) are presented as the objective was to compare PFS at 6 months in the experimental arm (triplet combination) against the historical PFS rate of 0.44 (equivalently a median PFS = 5 months) for carboplatin and etoposide. The control arm was planned primarily to reliably assess the safety of IMGN901 and to demonstrate whether the or not the historical assumptions regarding efficacy were confirmed.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
A total of 82 patients from the IMGN901 + carboplatin + etoposide safety population (N=94) were included in the efficacy analyses, due to the lack of post-baseline evaluations for 12 participants.
Arm/Group Title Phase II - IMGN901 + Carboplatin + Etoposide
Hide Arm/Group Description:
IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
Overall Number of Participants Analyzed 82
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
39
(28.4 to 50.4)
6.Secondary Outcome
Title Median Overall Survival (OS) in Phase II
Hide Description A secondary outcome measure for Phase II was to determine the overall survival of patients treated with IMGN901 in combination with carboplatin/etoposide chemotherapy versus carboplatin/etoposide chemotherapy alone as first-line treatment for patients with extensive stage small cell lung cancer.
Time Frame From the time of enrollment until death on study due to any cause (up to post-treatment follow-up 28 days after last dose, up to 22 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
A total of 121 patents were included in the analyses (82 in Arm1 and 39 in Arm 2) due to due to the lack of post-baseline evaluations for 20 participants.
Arm/Group Title Phase II - IMGN901 + Carboplatin + Etoposide Phase II - Carboplatin + Etoposide
Hide Arm/Group Description:
IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
Overall Number of Participants Analyzed 82 39
Median (95% Confidence Interval)
Unit of Measure: months
10.1
(8.7 to 18.1)
10.97
(7.5 to 11.4)
7.Secondary Outcome
Title Overall Survival (OS) Rate at 12 Months
Hide Description OS was analyzed based on a binary definition of the number of patients dead or censored prior to 12 months and the number of patients alive at 12 months. The primary objective of this phase of the study was to compare PFS in the experimental arm (triplet combination) against historical PFS rates. The control arm was primarily planned to demonstrate whether the or not the historical assumptions regarding efficacy were confirmed. Further, the trial was not empowered to permit a statistically informative comparison of the randomized treatment groups with respect to OS and no determination of the OS rate at 12 months for the control arm was performed; therefore only the results from the experimental arm (IMGN901 + carboplatin + etoposide) are presented.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
A total of 82 patients from the IMGN901 + carboplatin + etoposide safety population (N=94) were included in the efficacy analyses, due to the lack of post-baseline evaluations for 12 participants.
Arm/Group Title Phase II - IMGN901 + Carboplatin + Etoposide
Hide Arm/Group Description:
IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
Overall Number of Participants Analyzed 82
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants alive
61
(49.6 to 71.6)
Time Frame Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
Adverse Event Reporting Description AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
 
Arm/Group Title Phase I - IMGN901 + Carboplatin + Etoposide Phase II - IMGN901 + Carboplatin + Etoposide Phase II - Carboplatin + Etoposide
Hide Arm/Group Description Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease. IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease. Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
All-Cause Mortality
Phase I - IMGN901 + Carboplatin + Etoposide Phase II - IMGN901 + Carboplatin + Etoposide Phase II - Carboplatin + Etoposide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase I - IMGN901 + Carboplatin + Etoposide Phase II - IMGN901 + Carboplatin + Etoposide Phase II - Carboplatin + Etoposide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/33 (48.48%)   54/94 (57.45%)   23/47 (48.94%) 
Blood and lymphatic system disorders       
Anaemia  1  0/33 (0.00%)  2/94 (2.13%)  0/47 (0.00%) 
Febrile neutropenia  1  4/33 (12.12%)  6/94 (6.38%)  5/47 (10.64%) 
Neutropenia  1  0/33 (0.00%)  3/94 (3.19%)  1/47 (2.13%) 
Pancytopenia  1  1/33 (3.03%)  0/94 (0.00%)  0/47 (0.00%) 
Thrombocytopenia  1  1/33 (3.03%)  1/94 (1.06%)  2/47 (4.26%) 
Cardiac disorders       
Atrial defibrillation  1  1/33 (3.03%)  0/94 (0.00%)  1/47 (2.13%) 
Cardiac arrest  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Cardiac disorder  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Gastrointestinal disorders       
Constipation  1  1/33 (3.03%)  1/94 (1.06%)  0/47 (0.00%) 
Diarrhoea  1  0/33 (0.00%)  2/94 (2.13%)  2/47 (4.26%) 
Diverticular perforation  1  1/33 (3.03%)  0/94 (0.00%)  0/47 (0.00%) 
Pancreatitis  1  1/33 (3.03%)  0/94 (0.00%)  0/47 (0.00%) 
Abdominal pain  1  0/33 (0.00%)  0/94 (0.00%)  1/47 (2.13%) 
Abdominal pain upper  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Gastrointestinal heamorrhage  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Haematemesis  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Ileus  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Upper gastrointestinal heamorrhage  1  0/33 (0.00%)  0/94 (0.00%)  1/47 (2.13%) 
Vomiting  1  0/33 (0.00%)  0/94 (0.00%)  1/47 (2.13%) 
General disorders       
Non-cardiac chest pain  1  1/33 (3.03%)  2/94 (2.13%)  0/47 (0.00%) 
Pain  1  1/33 (3.03%)  2/94 (2.13%)  0/47 (0.00%) 
Pyrexia  1  0/33 (0.00%)  2/94 (2.13%)  0/47 (0.00%) 
Disease progression  1  0/33 (0.00%)  1/94 (1.06%)  1/47 (2.13%) 
Fatigue  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Hepatobiliary disorders       
Hepatic cirrhosis  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Infections and infestations       
Bacteraemia  1  1/33 (3.03%)  0/94 (0.00%)  0/47 (0.00%) 
Cellulitis  1  0/33 (0.00%)  2/94 (2.13%)  0/47 (0.00%) 
Clostridium difficile colitis  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Lobar pneumonia  1  1/33 (3.03%)  0/94 (0.00%)  0/47 (0.00%) 
Lower respiratory tract infection  1  0/33 (0.00%)  2/94 (2.13%)  0/47 (0.00%) 
Neutropenic sepsis  1  0/33 (0.00%)  4/94 (4.26%)  1/47 (2.13%) 
Pneumonia  1  0/33 (0.00%)  6/94 (6.38%)  2/47 (4.26%) 
Sepsis  1  2/33 (6.06%)  2/94 (2.13%)  1/47 (2.13%) 
Septic shock  1  0/33 (0.00%)  3/94 (3.19%)  0/47 (0.00%) 
Respiratory tract infection  1  0/33 (0.00%)  1/94 (1.06%)  1/47 (2.13%) 
Device related infection  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Viral infection  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Injury, poisoning and procedural complications       
Femur fracture  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Spinal compression fracture  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Fracture  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Investigations       
Ejection fraction decreased  1  0/33 (0.00%)  0/94 (0.00%)  1/47 (2.13%) 
Neutrophil count decreased  1  0/33 (0.00%)  0/94 (0.00%)  1/47 (2.13%) 
Transaminases increased  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  0/33 (0.00%)  3/94 (3.19%)  1/47 (2.13%) 
Hypercalcaemia  1  1/33 (3.03%)  0/94 (0.00%)  0/47 (0.00%) 
Hypomagnesaemia  1  1/33 (3.03%)  0/94 (0.00%)  0/47 (0.00%) 
Hyponatraemia  1  0/33 (0.00%)  0/94 (0.00%)  1/47 (2.13%) 
Electrolyte imbalance  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Failure to thrive  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Muscular weakness  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Metastases to central nervous system  1  0/33 (0.00%)  1/94 (1.06%)  1/47 (2.13%) 
Renal cancer metastatic  1  0/33 (0.00%)  0/94 (0.00%)  1/47 (2.13%) 
Nervous system disorders       
Convulsion  1  1/33 (3.03%)  1/94 (1.06%)  0/47 (0.00%) 
Nerve root compression  1  1/33 (3.03%)  0/94 (0.00%)  0/47 (0.00%) 
Peripheral sensory neuropathy  1  0/33 (0.00%)  3/94 (3.19%)  0/47 (0.00%) 
Peripheral sensorimotor neuropathy  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Polyneuropathy  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Syncope  1  0/33 (0.00%)  1/94 (1.06%)  1/47 (2.13%) 
Psychiatric disorders       
Completed suicide  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Confusional state  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Delirium  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Hallucination  1  0/33 (0.00%)  0/94 (0.00%)  1/47 (2.13%) 
Reproductive system and breast disorders       
Vulval haemorrhage  1  1/33 (3.03%)  0/94 (0.00%)  0/47 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/33 (0.00%)  2/94 (2.13%)  0/47 (0.00%) 
Pulmonary embolism  1  0/33 (0.00%)  5/94 (5.32%)  0/47 (0.00%) 
Dyspnoea  1  0/33 (0.00%)  0/94 (0.00%)  1/47 (2.13%) 
Haemoptysis  1  0/33 (0.00%)  1/94 (1.06%)  2/47 (4.26%) 
Hypoxia  1  0/33 (0.00%)  0/94 (0.00%)  1/47 (2.13%) 
Laryngeal inflammation  1  0/33 (0.00%)  0/94 (0.00%)  1/47 (2.13%) 
Pleural effusion  1  0/33 (0.00%)  1/94 (1.06%)  1/47 (2.13%) 
Pulmonary oedema  1  0/33 (0.00%)  0/94 (0.00%)  1/47 (2.13%) 
Respiratory distress  1  0/33 (0.00%)  0/94 (0.00%)  1/47 (2.13%) 
Respiratory failure  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Vascular disorders       
Deep vein thrombosis  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Hypotension  1  0/33 (0.00%)  2/94 (2.13%)  0/47 (0.00%) 
Hypertension  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Peripheral ischaemia  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Arterial thrombosis limb  1  0/33 (0.00%)  1/94 (1.06%)  0/47 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase I - IMGN901 + Carboplatin + Etoposide Phase II - IMGN901 + Carboplatin + Etoposide Phase II - Carboplatin + Etoposide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   33/33 (100.00%)   91/94 (96.81%)   43/47 (91.49%) 
Blood and lymphatic system disorders       
Anaemia  1  24/33 (72.73%)  50/94 (53.19%)  21/47 (44.68%) 
Leukocytosis  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Leukopenia  1  9/33 (27.27%)  10/94 (10.64%)  6/47 (12.77%) 
Lymphopenia  1  4/33 (12.12%)  0/94 (0.00%)  0/47 (0.00%) 
Neutropenia  1  10/33 (30.30%)  53/94 (56.38%)  24/47 (51.06%) 
Pancytopenia  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Thrombocytopenia  1  16/33 (48.48%)  32/94 (34.04%)  19/47 (40.43%) 
Cardiac disorders       
Sinus tachycardia  1  0/33 (0.00%)  5/94 (5.32%)  0/47 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  8/33 (24.24%)  5/94 (5.32%)  3/47 (6.38%) 
Constipation  1  12/33 (36.36%)  30/94 (31.91%)  9/47 (19.15%) 
Diarrhoea  1  9/33 (27.27%)  30/94 (31.91%)  8/47 (17.02%) 
Dyspepsia  1  6/33 (18.18%)  13/94 (13.83%)  0/47 (0.00%) 
Dysphagia  1  3/33 (9.09%)  1/94 (1.06%)  4/47 (8.51%) 
Flatulence  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Nausea  1  13/33 (39.39%)  40/94 (42.55%)  17/47 (36.17%) 
Vomiting  1  11/33 (33.33%)  23/94 (24.47%)  11/47 (23.40%) 
Abdominal distension  1  0/33 (0.00%)  5/94 (5.32%)  0/47 (0.00%) 
Abdominal pain upper  1  0/33 (0.00%)  6/94 (6.38%)  2/47 (4.26%) 
Stomatitis  1  0/33 (0.00%)  6/94 (6.38%)  2/47 (4.26%) 
General disorders       
Asthenia  1  3/33 (9.09%)  29/94 (30.85%)  10/47 (21.28%) 
Chills  1  2/33 (6.06%)  6/94 (6.38%)  2/47 (4.26%) 
Fatigue  1  17/33 (51.52%)  46/94 (48.94%)  14/47 (29.79%) 
Influenza like illness  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Mucosal inflammation  1  2/33 (6.06%)  13/94 (13.83%)  6/47 (12.77%) 
Oedema peripheral  1  3/33 (9.09%)  19/94 (20.21%)  5/47 (10.64%) 
Pain  1  5/33 (15.15%)  7/94 (7.45%)  2/47 (4.26%) 
Pyrexia  1  8/33 (24.24%)  10/94 (10.64%)  5/47 (10.64%) 
Malaise  1  0/33 (0.00%)  6/94 (6.38%)  0/47 (0.00%) 
Non-cardiac chest pain  1  0/33 (0.00%)  7/94 (7.45%)  6/47 (12.77%) 
Infections and infestations       
Oral candidiasis  1  3/33 (9.09%)  5/94 (5.32%)  2/47 (4.26%) 
Urinary tract infection  1  5/33 (15.15%)  10/94 (10.64%)  7/47 (14.89%) 
Upper respiratory tract infection  1  0/33 (0.00%)  6/94 (6.38%)  2/47 (4.26%) 
Injury, poisoning and procedural complications       
Fall  1  3/33 (9.09%)  0/94 (0.00%)  0/47 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  2/33 (6.06%)  11/94 (11.70%)  0/47 (0.00%) 
Aspartate aminotransferase increased  1  2/33 (6.06%)  8/94 (8.51%)  1/47 (2.13%) 
Blood alkaline phosphatase increased  1  2/33 (6.06%)  8/94 (8.51%)  1/47 (2.13%) 
Blood creatine increased  1  3/33 (9.09%)  2/94 (2.13%)  3/47 (6.38%) 
Blood pressure increased  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Gamma-glutamyltransferase increased  1  3/33 (9.09%)  0/94 (0.00%)  0/47 (0.00%) 
Lipase increased  1  2/33 (6.06%)  3/94 (3.19%)  3/47 (6.38%) 
Lymphocyte count decreased  1  7/33 (21.21%)  0/94 (0.00%)  0/47 (0.00%) 
Neutrophil count decreased  1  7/33 (21.21%)  11/94 (11.70%)  7/47 (14.89%) 
Platelet count decreased  1  2/33 (6.06%)  16/94 (17.02%)  6/47 (12.77%) 
Weight decreased  1  2/33 (6.06%)  7/94 (7.45%)  3/47 (6.38%) 
White blood cell count decreased  1  7/33 (21.21%)  8/94 (8.51%)  4/47 (8.51%) 
Blood amylase increased  1  0/33 (0.00%)  7/94 (7.45%)  2/47 (4.26%) 
Metabolism and nutrition disorders       
Decreased appetite  1  6/33 (18.18%)  32/94 (34.04%)  16/47 (34.04%) 
Dehydration  1  3/33 (9.09%)  15/94 (15.96%)  6/47 (12.77%) 
Hypercalcaemia  1  3/33 (9.09%)  0/94 (0.00%)  0/47 (0.00%) 
Hyperglycaemia  1  2/33 (6.06%)  5/94 (5.32%)  2/47 (4.26%) 
Hypoalbuminaemia  1  3/33 (9.09%)  0/94 (0.00%)  0/47 (0.00%) 
Hypocalcaemia  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Hypokalaemia  1  9/33 (27.27%)  13/94 (13.83%)  3/47 (6.38%) 
Hypomagnesaemia  1  7/33 (21.21%)  16/94 (17.02%)  6/47 (12.77%) 
Hyponatraemia  1  8/33 (24.24%)  12/94 (12.77%)  6/47 (12.77%) 
Hypophospataemia  1  5/33 (15.15%)  5/94 (5.32%)  1/47 (2.13%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  8/33 (24.24%)  18/94 (19.15%)  5/47 (10.64%) 
Back pain  1  4/33 (12.12%)  12/94 (12.77%)  4/47 (8.51%) 
Bone pain  1  2/33 (6.06%)  5/94 (5.32%)  3/47 (6.38%) 
Muscle spasms  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Muscular weakness  1  2/33 (6.06%)  6/94 (6.38%)  2/47 (4.26%) 
Musculoskeletal chest pain  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Musculoskeletal pain  1  2/33 (6.06%)  7/94 (7.45%)  2/47 (4.26%) 
Neck pain  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Pain in extremity  1  6/33 (18.18%)  11/94 (11.70%)  3/47 (6.38%) 
Myalgia  1  0/33 (0.00%)  12/94 (12.77%)  3/47 (6.38%) 
Nervous system disorders       
Dizziness  1  3/33 (9.09%)  13/94 (13.83%)  5/47 (10.64%) 
Dysgeusia  1  4/33 (12.12%)  10/94 (10.64%)  6/47 (12.77%) 
Headache  1  7/33 (21.21%)  16/94 (17.02%)  5/47 (10.64%) 
Paraesthesia  1  2/33 (6.06%)  20/94 (21.28%)  2/47 (4.26%) 
Peripheral motor neuropathy  1  2/33 (6.06%)  7/94 (7.45%)  0/47 (0.00%) 
Peripheral sensory neuropathy  1  17/33 (51.52%)  56/94 (59.57%)  4/47 (8.51%) 
Restless legs syndrome  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Hyporeflexia  1  0/33 (0.00%)  0/94 (0.00%)  3/47 (6.38%) 
Neurotoxicity  1  0/33 (0.00%)  8/94 (8.51%)  1/47 (2.13%) 
Psychiatric disorders       
Anxiety  1  2/33 (6.06%)  8/94 (8.51%)  1/47 (2.13%) 
Depression  1  2/33 (6.06%)  5/94 (5.32%)  1/47 (2.13%) 
Insomnia  1  6/33 (18.18%)  19/94 (20.21%)  4/47 (8.51%) 
Renal and urinary disorders       
Dysuria  1  4/33 (12.12%)  0/94 (0.00%)  0/47 (0.00%) 
Urinary retention  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  6/33 (18.18%)  11/94 (11.70%)  10/47 (21.28%) 
Dysphonia  1  2/33 (6.06%)  8/94 (8.51%)  2/47 (4.26%) 
Dyspnoea  1  5/33 (15.15%)  18/94 (19.15%)  7/47 (14.89%) 
Epistaxis  1  2/33 (6.06%)  5/94 (5.32%)  2/47 (4.26%) 
Oropharyngeal pain  1  5/33 (15.15%)  0/94 (0.00%)  0/47 (0.00%) 
Pulmonary embolism  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Haemoptysis  1  0/33 (0.00%)  6/94 (6.38%)  1/47 (2.13%) 
Hiccups  1  0/33 (0.00%)  0/94 (0.00%)  3/47 (6.38%) 
Hypoxia  1  0/33 (0.00%)  5/94 (5.32%)  1/47 (2.13%) 
Productive cough  1  0/33 (0.00%)  2/94 (2.13%)  4/47 (8.51%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  10/33 (30.30%)  32/94 (34.04%)  16/47 (34.04%) 
Dry skin  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Erythema  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Skin lesion  1  2/33 (6.06%)  0/94 (0.00%)  0/47 (0.00%) 
Pruritis  1  0/33 (0.00%)  6/94 (6.38%)  1/47 (2.13%) 
Vascular disorders       
Hypertension  1  2/33 (6.06%)  7/94 (7.45%)  0/47 (0.00%) 
Hypotension  1  2/33 (6.06%)  10/94 (10.64%)  4/47 (8.51%) 
Hot flush  1  0/33 (0.00%)  5/94 (5.32%)  0/47 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
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
Name/Title: Dr. Richard Bates, Sr. Manager, Publications
Organization: ImmunoGen Inc.
Phone: 781 895 0196
Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT01237678     History of Changes
Other Study ID Numbers: Immunogen 0007
First Submitted: November 8, 2010
First Posted: November 9, 2010
Results First Submitted: April 1, 2016
Results First Posted: January 18, 2018
Last Update Posted: January 18, 2018