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
18 Years
N/A
Both
Small Cell Lung Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Occurrence of Dose Limiting Toxicities (DLT)
Outcome Description:
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.
Outcome Time Frame:
30 months
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
Immunogen 0007
NCT ID:
NCT01237678
Start Date:
November 2010
Completion Date:
July 2015
Related Keywords:
- Small Cell Lung Cancer
- Immunogen
- Lung
- Small Cell Lung Cancer
- Carboplatin
- ADC
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| Johns Hopkins University | Baltimore, Maryland 21205 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| University Hospitals of Cleveland | Cleveland, Ohio 44106 |
| Sibley Memorial Hospital | Washington, District of Columbia 20016 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| Anne Arundel Medical Center | Annapolis, Maryland 21401 |
| Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
| South Carolina Oncology Associates | Columbia, South Carolina 29201 |
| University of Florida | Gainesville, Florida 32610-0277 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Oregon Health and Science University | Portland, Oregon 97201 |
| Northwest Medical Specialties | Tacoma, Washington 98405 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
| Oklahoma University | Tulsa, Oklahoma 74104 |
| UCLA Oncology Center | Los Angeles, California 90095 |
| St. Joseph's Hospital | Orange, California 92868 |
| Arizona Cancer Center @ UMC North | Tucson, Arizona 85719 |
| Holy Cross Hospital Bienes Comprehensive Cancer Center | Fort Lauderdale, Florida 33308 |
| Johnson Therurer Cancer Center at Hackensack | Hackensack, New Jersey 07601 |
| UTHSC at San Antonio | San Antonio, Texas 78229 |
| UCLA Hematology | Pasadena, California 91105 |
| UCLA Oncology Clinic | Santa Monica, California 90404 |
| UCLA Santa Clarita Valley Cancer Center | Valencia, California 91355 |
| Yale Medical Center | New Haven, Connecticut 06510 |
| Bayview Medical Center | Baltimore, Maryland 21224 |
| UPMC Cancer Centers East, Oxford Drive | Monroeville, Pennsylvania 15146 |
| UPMC Cancer Center at UPMC Passavant (HOA) | Pittsburg, Pennsylvania 15237 |
| UPMC Cancer Center St. Margaret | Pittsburg, Pennsylvania 15215 |
| Univeristy of Pittsburg Medical Center | Pittsburgh, Pennsylvania 15232 |
| University of Tennessee Medical Center Cancer Institute | Knoxville, Tennessee 37920 |
