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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened during a 28-day period

Reporting Groups
  Description
Phase I - IMGN901 + Carboplatin + Etoposide 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.
Phase II - IMGN901 + Carboplatin + Etoposide 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.
Phase II - Carboplatin + Etoposide 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.

Participant Flow for 2 periods

Period 1:   Phase I - IMGN901+Carboplatin+Etoposide
    Phase I - IMGN901 + Carboplatin + Etoposide   Phase II - IMGN901 + Carboplatin + Etoposide   Phase II - Carboplatin + Etoposide
STARTED   33   0   0 
Received Intervention   33   0   0 
COMPLETED   0   0   0 
NOT COMPLETED   33   0   0 
Adverse Event                5                0                0 
Lack of Efficacy                24                0                0 
Withdrawal by Subject                3                0                0 
Incorrect Original Diagnosis                1                0                0 

Period 2:   Phase II
    Phase I - IMGN901 + Carboplatin + Etoposide   Phase II - IMGN901 + Carboplatin + Etoposide   Phase II - Carboplatin + Etoposide
STARTED   0   98 [1]   50 [2] 
Received Intervention   0   94   47 
COMPLETED   0   0   0 
NOT COMPLETED   0   98   50 
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



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Phase I - IMGN901 + Carboplatin + Etoposide 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.
Phase II - IMGN901 + Carboplatin + Etoposide 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.
Phase II - Carboplatin + Etoposide 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 Total of all reporting groups

Baseline Measures
   Phase I - IMGN901 + Carboplatin + Etoposide   Phase II - IMGN901 + Carboplatin + Etoposide   Phase II - Carboplatin + Etoposide   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   94   47   174 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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] 
[Units: Participants]
Count of Participants
       
 14   22   12   48 
 19   62   32   113 
 0   10   3   13 
[1]

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 
[Units: Participants]
       
Yes   21   93   46   160 
No   12   1   1   14 


  Outcome Measures

1.  Primary:   Occurrence of Dose Limiting Toxicities (DLT)   [ Time Frame: 21 days (Cycle 1) ]

2.  Primary:   Progression Free Survival (PFS) in Phase II   [ 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) ]

3.  Primary:   Maximum Tolerated Dose (MTD) of IMGN901   [ Time Frame: 21 days (Cycle 1) ]

4.  Secondary:   Overview of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)   [ 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) ]

5.  Secondary:   Progression Free Survival (PFS) Rate at 6 Months   [ Time Frame: 6 months ]

6.  Secondary:   Median Overall Survival (OS) in Phase II   [ 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) ]

7.  Secondary:   Overall Survival (OS) Rate at 12 Months   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: Richard.Bates@immunogen.com



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