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

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