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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT01237678
First received: November 8, 2010
Last updated: November 19, 2013
Last verified: November 2013

November 8, 2010
November 19, 2013
November 2010
July 2015   (final data collection date for primary outcome measure)
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.

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.
Complete list of historical versions of study NCT01237678 on ClinicalTrials.gov Archive Site
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

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
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Small Cell Lung Cancer
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
145
July 2015
July 2015   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Spain,   United Kingdom
 
NCT01237678
Immunogen 0007
Yes
ImmunoGen, Inc.
ImmunoGen, Inc.
Not Provided
Not Provided
ImmunoGen, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP