NCT01395017

Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer

Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	dasatinib	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.
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-10-01
• Completion: 2015-03-01
• First posted: 2011-07-15
• Last updated: 2016-04-08
• Results posted: 2015-03-17

Locations

74 sites across 15 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Ireland, Italy, Poland, Romania, Russia, United Kingdom