The purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
202
GEM 1000 mg/m2 by intravenous \[IV\] infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg (or matched placebo) by mouth once daily (QD). Subjects will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Matching Placebo
Overall Survival
Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.
Time frame: From randomization until date of death from any cause by 02 December 2013
Progression Free Survival (PFS)
PFS - time from randomization to unequivocal local or distant disease progression, death or discontinuation from trial for any reason by 02 December 2013. Progression events were determined according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 every 8 weeks.
Time frame: Time from randomization to earliest PFS event by 02 December 2013
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Birmingham, Alabama, United States
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Los Angeles, California, United States
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Orange, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Boynton Beach, Florida, United States
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Tampa, Florida, United States
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Wichita, Kansas, United States
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Minneapolis, Minnesota, United States
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Albuquerque, New Mexico, United States
...and 64 more locations