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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.

Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

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.

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.

Inclusion Criteria:

- Metastatic Colorectal Carcinoma with KRAS mutation.

- Received first line therapy and discontinued part or all of first line therapy.

- Estimated life expectancy > 3 months.

- Stage IV disease.

- ECOG 0-2.

- Adequate hepatic and hematologic function

- No major operations within 4 weeks prior to treatment start.

Exclusion Criteria:

- 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.

- Known dihydropyrimidine dehydrogenase-deficiency (special screening not required).

- Subjects with angina pectoris, poorly controlled ventricular arrhythmias (does not
include asymptomatic, occasional premature ventricular contractions), history of
clinically significant coronary heart disease or cardiomyopathy, or ECG abnormalities
consistent with ischemia.

- Uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic
blood pressure > 110 mmHg) at Screening.

- Clinically active liver disease, including active hepatitis (any etiology) or

- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy,
retinoid therapy, hormonal therapy) within 21 days prior to randomization

- Prior irinotecan therapy for metastatic disease is not permitted.

- Systemic fungal, bacterial, viral, or other infection.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

Safety Issue:


Principal Investigator

Mike Hawkins, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

June 2014

Related Keywords:

  • Colorectal Cancer
  • GSI
  • Gilead
  • Gilead Sciences
  • GS-6624
  • Colorectal Cancer
  • KRAS
  • Oncology
  • monoclonal antibody
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms



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