Efficacy and Safety of GS-6624 With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma
Phase: Phase 2
Diagnosis: Gastrointestinal Malignancies, Colorectal Cancer
NCT ID: NCT01479465
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-040
This randomized study compares the efficacy of GS-6624 versus placebo in combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) chemotherapy regimen in participants with metastatic KRAS or BRAF mutant colorectal cancer.
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital
Jeffrey Meyerhardt, MD,
Dana-Farber Cancer Institute
Andrea Bullock, M.D.,
Beth Israel Deaconess Medical Center
Eunice Kwak, MD,
Massachusetts General Hospital
Dana-Farber Cancer Institute:
Gastrointestinal Research Line, 617-632-5960
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
- Metastatic Colorectal Carcinoma with KRAS mutation
- Stage IV disease.
- ECOG 0-2.
- Adequate hepatic and hematologic function
- No major operations within 4 weeks prior to treatment start.
- More than 1 prior chemotherapy regimen for stage 4 colorectal cancer.
- Experimental medical treatment within 30 days prior to study entry.
- Known or suspected cerebral metastases.
- History or presence of any form of cancer, other that colorectal cancer, within the 3
years prior to enrollment.
- Myocardial infarction within the last 6 months
- Systemic fungal, bacterial, viral, or other infection