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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
Arizona Cancer Center @ UMC North
Tucson, Arizona, United States, 85719
United States, California
UCLA Oncology Center
Los Angeles, California, United States, 90095
St. Joseph's Hospital
Orange, California, United States, 92868
UCLA Hematology
Pasadena, California, United States, 91105
UCLA Oncology Clinic
Santa Monica, California, United States, 90404
UCLA Santa Clarita Valley Cancer Center
Valencia, California, United States, 91355
UCLA Oncology Center
Westlake Village, California, United States, 91361
United States, Connecticut
Yale Medical Center
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
Holy Cross Hospital Bienes Comprehensive Cancer Center
Fort Lauderdale, Florida, United States, 33308
University of Florida
Gainesville, Florida, United States, 32608
United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Bayview Medical Center
Baltimore, Maryland, United States, 21224
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2696
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New Jersey
Johnson Therurer Cancer Center at Hackensack
Hackensack, New Jersey, United States, 07601
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Oklahoma University
Oklahoma City, Oklahoma, United States, 73104-5417
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
UPMC Cancer Centers East, Oxford Drive
Monroeville, Pennsylvania, United States, 15146
UPMC Cancer Center at UPMC Passavant (HOA)
Pittsburg, Pennsylvania, United States, 15237
UPMC Cancer Center St. Margaret
Pittsburg, Pennsylvania, United States, 15215
Univeristy of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
South Carolina Oncology Associates
Columbia, South Carolina, United States, 29210
United States, Tennessee
University of Tennessee Medical Center Cancer Institute
Knoxville, Tennessee, United States, 37920
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
UTHSC at San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Canada, Ontario
Juravinski Cancer Center
Hamilton, Ontario, Canada, L8V 5C2
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Royal Victoria
Montreal, Quebec, Canada, QC H3G
St. Mary's Hospital
Montreal, Quebec, Canada, H3T 1M5
Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital de la Santa Creu y Sand Pau
Barcelona, Spain, 08041
Hospital Universitario
Madrid, Spain, 28222
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
United Kingdom
Royal Sussex Hospital
Brighton, East Sussex, United Kingdom, BN2 5BE
University College of London
London, England, United Kingdom, NM12BU
The Christie Hospital
Withington, Manchester, United Kingdom, M20 4BX
Royal Marsden, Sutton
Downs Road, Sutton, United Kingdom, SM2 5PT
Royal Marsden, London
London, United Kingdom, SW3 6JJ
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: November 19, 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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Ado-trastuzumab emtansine
Carboplatin
Etoposide
Etoposide phosphate
Maytansine
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014