A Study to Test Safety and Efficacy of IMGN901 in Combination With Carboplatin/Etoposide in Patients With Advanced Solid Tumors and Extensive Stage Small Cell Lung Cancer

This study is currently recruiting participants.

Verified April 2013 by ImmunoGen, Inc.

Sponsor:

Information provided by (Responsible Party):

ImmunoGen, Inc.

ClinicalTrials.gov Identifier:

NCT01237678

First received: November 8, 2010

Last updated: April 24, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	November 8, 2010
Last Updated Date	April 24, 2013
Start Date ^ICMJE	November 2010
Estimated Primary Completion Date	July 2015 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 28, 2012)	Occurrence of Dose Limiting Toxicities (DLT) [ Time Frame: 30 months ] [ Designated as safety issue: Yes ] Phase 1: 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. Phase 2: to determine the efficacy of IMGN901 in combination with carboplatin/etoposide chemotherapy followed by IMGN901 alone versus carboplatin/etoposide chemotherapy as first-line treatment for patients with extensive stage small cell lung cancer.
Original Primary Outcome Measures ^ICMJE (submitted: November 8, 2010)	Occurrence of Dose Limiting Toxicities (DLT) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ] Phase 1: 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. Phase 2: to determine the efficacy of IMGN901 in combination with carboplatin/etoposide chemotherapy followed by IMGN901 alone versus carboplatin/etoposide chemotherapy as first-line treatment for patients with extensive stage small cell lung cancer.
Change History	Complete list of historical versions of study NCT01237678 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 28, 2012)	Type and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 30 months ] [ Designated as safety issue: Yes ] Phase I: to assess the safety and tolerability, including all toxicities; determine pharmacokinetics (PK) of IMGN901, carboplatin and etoposide; describe anti-tumor activity; assess the immunogenicity of IMGN901 in this combination in patients with solid tumors. Phase 2: to determine safety and tolerability of IMGN901 in this combination followed by IMGN901 alone versus carboplatin/etoposide and to assess the immunogenicity of IMGN901 in combination with carboplatin/etoposide in patients with SCLC-ED in a first line setting
Original Secondary Outcome Measures ^ICMJE (submitted: November 8, 2010)	Type and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ] Phase I: to assess the safety and tolerability, including all toxicities; determine pharmacokinetics (PK) of IMGN901, carboplatin and etoposide; describe anti-tumor activity; assess the immunogenicity of IMGN901 in this combination in patients with solid tumors. Phase 2: to determine safety and tolerability of IMGN901 in this combination followed by IMGN901 alone versus carboplatin/etoposide and to assess the immunogenicity of IMGN901 in combination with carboplatin/etoposide in patients with SCLC-ED in a first line setting
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Test Safety and Efficacy of IMGN901 in Combination With Carboplatin/Etoposide in Patients With Advanced Solid Tumors and Extensive Stage Small Cell Lung Cancer
Official Title ^ICMJE	A Phase 1/2 Study to Assess the Safety and Efficacy of Lorvotuzumab Mertansine in Combination With Carboplatin/Etoposide in Patients With Advanced Solid Tumors Including Extensive Stage Small Cell Lung Cancer
Brief Summary	The purpose of this study is to test safety and efficacy of this combination treatment (IMGN901, carboplatin and etoposide) in patients with solid tumors and extensive stage small cell lung cancer.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Small Cell Lung Cancer
Intervention ^ICMJE	Drug: IMGN901 Phase 2 regimen is IMGN901, Carboplatin, and Etoposide. IMGN901 to be given on days 1 and 8 every 21 days. Other Name: BB-10901, Lorvotuzumab mertansine Drug: Carboplatin and Etoposide
Study Arm (s)	Experimental: IMGN901 with carboplatin/etoposide followed by IMGN901 alone. Patients will receive IMGN901 along with carboplatin and etoposide for up to 6 cycles and then be able to continue on IMGN901 alone until no further benefit or toxicity. Intervention: Drug: IMGN901 Active Comparator: Standard of Care - Carboplatin/Etoposide Patients will receive Carboplatin/etoposide for up to 6 cycles. Intervention: Drug: Carboplatin and Etoposide
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	145
Estimated Completion Date	July 2015
Estimated Primary Completion Date	July 2015 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients must be 18 years old Patients must have been diagnosed with small-cell lung cancer (SCLC) and extensive disease ECOG performance status of 0, 1, or 2 No prior systemic chemotherapy for the treatment of SCLC Exclusion Criteria: - Pregnant or lactating females
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States, Canada, Spain, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01237678
Other Study ID Numbers ^ICMJE	Immunogen 0007
Has Data Monitoring Committee	Yes
Responsible Party	ImmunoGen, Inc.
Study Sponsor ^ICMJE	ImmunoGen, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	ImmunoGen, Inc.
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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