GS-6624 With FOLFIRI as Second Line Treatment for Colorectal Cancer (11053)
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With FOLFIRI as Second Line Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma That Has Progressed Following a First Line Oxaliplatin- and Fluoropyrimidine-Containing Regimen.
|Closed||Colorectal Cancer||Phase II||
This randomized Phase 2 study compares the additive efficacy of GS-6624 versus placebo in combination with FOLFIRI in subjects with metastatic KRAS or BRAF mutant colorectal cancer.
Eligibility Criteria (must meet the following to participate in this study)
- 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.
Exclusions (conditions that would prevent participation in this study)
- 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
Last UpdatedSeptember 12, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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