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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 currently recruiting participants.
Verified June 2013 by ImmunoGen, Inc.
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT01237678
First received: November 8, 2010
Last updated: June 14, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Cancer
 Drug: IMGN901
Drug: Carboplatin and Etoposide
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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



Estimated Enrollment: 145
Study Start Date: November 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
Active Comparator: Standard of Care - Carboplatin/Etoposide
Patients will receive Carboplatin/etoposide for up to 6 cycles.
 Drug: Carboplatin and Etoposide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237678

  Show 48 Study Locations
Sponsors and Collaborators
ImmunoGen, Inc.
  More Information

No publications provided

Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT01237678     History of Changes
Other Study ID Numbers: Immunogen 0007
Study First Received: November 8, 2010
Last Updated: June 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ImmunoGen, Inc.:
Immunogen
Lung
Small Cell Lung Cancer
Carboplatin
ADC

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Etoposide
Etoposide phosphate
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013