Phase II Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone Administered Intravenously to Patients With Colorectal Adenocarcinoma Previously Untreated for Metastatic Disease
The proposed clinical trial will be a multi-center, randomized, open label, active control
study in previously untreated patients with metastatic colorectal cancer aimed to evaluate
the safety, tolerability and efficacy of the monoclonal antibody, CT-011, administered at
3mg/kg in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment
by FOLFOX alone. Approximately 168 patients are planned to be enrolled to this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint will be the median progression free survival in patients treated with CT-011 plus FOLFOX compared to that of patients treated with FOLFOX alone.
Leonard B Saltz, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Joe Arrington Cancer Research and Treatment Center||Lubbock, Texas 79410-1894|
|University of South Florida||Tampa, Florida 33612|
|Signal Point Clinical Research Center||Middletown, Ohio 45042|
|The Cancer Center of Huntsville, PC||Huntsville, Alabama 35801|