Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments simtuzumab, folfiri, placebo to match simtuzumab
Phase phase 2
Sponsor Gilead Sciences
Start date December 2011
End date October 2014
Trial size 266 participants
Trial identifier NCT01479465, 2011-003754-61, GS-US-295-0203

Summary

This randomized study compares the efficacy of simtuzumab (GS-6624) versus placebo in combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) chemotherapy regimen in participants with metastatic KRAS mutant colorectal cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Open-label, non-randomized: Participants will receive simtuzumab 700 mg followed by FOLFIRI for one cycle and continue with 28-day treatment cycles during their entire participation.
simtuzumab GS-6624
Simtuzumab administered intravenously biweekly
folfiri
FOLFIRI administered intravenously biweekly
(Experimental)
Randomized, double blind, placebo-controlled portion; Participants will receive 28-day treatment cycles of simtuzumab 200 mg followed by FOLFIRI for approximately 20 months.
simtuzumab GS-6624
Simtuzumab administered intravenously biweekly
folfiri
FOLFIRI administered intravenously biweekly
(Experimental)
Randomized, double blind, placebo-controlled portion; Participants will receive 28-day treatment cycles of simtuzumab 700 mg followed by FOLFIRI for approximately 20 months.
simtuzumab GS-6624
Simtuzumab administered intravenously biweekly
folfiri
FOLFIRI administered intravenously biweekly
(Experimental)
Randomized, double blind, placebo-controlled portion; Participants will receive 28-day treatment cycles of placebo to match simtuzumab followed by FOLFIRI for approximately 20 months.
folfiri
FOLFIRI administered intravenously biweekly
placebo to match simtuzumab
Placebo to match simtuzumab administered intravenously biweekly

Primary Outcomes

Measure
Progression Free Survival
time frame: Up to 20 months

Secondary Outcomes

Measure
Overall survival
time frame: Up to 20 months
Objective response
time frame: Up to 20 months

Eligibility Criteria

Male or female participants at least 18 years old.

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. - Eastern Cooperative Oncology Group (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 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.

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Gilead Sciences.