This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
250
Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)
Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)
Progression free survival
Progression free survival is measured as time from date of randomization to the earliest event time of death regardless of cause or first indication of disease progression.
Time frame: Up to 3 years
Overall survival
Overall survival is measured as time from date of randomization to death regardless of cause.
Time frame: Up to 3 years
Objective response
Objective response is assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as complete response, partial response, stable disease, or progressive disease.
Time frame: Up to 3 years
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