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Trial record 1 of 3 for:    LUNG IMGN901
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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01237678
First Posted: November 9, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ImmunoGen, Inc.
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • Occurrence of Dose Limiting Toxicities (DLT) [ Time Frame: 30 months ]

    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 ]

    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
Study Completion Date: May 2015
Primary Completion Date: May 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237678


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

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
Last Update Posted: October 12, 2017
Last Verified: August 2015

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

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Lung Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Ado-trastuzumab emtansine
Carboplatin
Etoposide
Maytansine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators