Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer (LAPC)
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|ClinicalTrials.gov Identifier: NCT01395017|
Recruitment Status : Completed
First Posted : July 15, 2011
Results First Posted : March 17, 2015
Last Update Posted : April 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: dasatinib Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||202 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||March 2015|
Active Comparator: Group 1
One arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous [IV] infusion weekly for 3 weeks of a 4-week cycle) plus dasatinib 100 mg by mouth once daily (QD).
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.
Other Name: BMS-354825
Placebo Comparator: Group 2
The other arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous [IV] infusion weekly for 3 weeks of a 4-week cycle) plus matched placebo by mouth once daily (QD).
- Overall Survival [ Time Frame: From randomization until date of death from any cause by 02 December 2013 ]Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.
- Progression Free Survival (PFS) [ Time Frame: Time from randomization to earliest PFS event by 02 December 2013 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395017