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Colorectal Cancer

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.
Status Conditions Phase Study ID
Recruiting Colorectal Cancer Phase II 11053
NCT01479465
Summary

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.


Investigator
Andrew Coveler, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
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 Updated
December 03, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.