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Complete title: Gilead GS-US-295-0203: 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 or BRAF Mutant Colorectal Adenocarcinoma that Has Progressed Following a First Line Oxaliplatin- and Fluoropyrimidine-Containing Regimen
|Research Study Number||20111441|
|Principal Investigator||Andrew Coveler, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- 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.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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 cirrhosis.
- 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
Other exclusion criteria may apply.
Colon Cancer; Solid Tumors
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