CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 202 enrolled
Drug / intervention
dasatinib +1 moredrug
Likely dose
dasatinib 1000 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01395017
NCT01395017Phase 2Completed

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

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jul 15, 2011·Updated Apr 8, 2016

In Brief

A Phase 2 clinical trial evaluating dasatinib and Placebo for Pancreatic Cancer. Completed, enrolled 202 participants across 74 sites in 15 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Ireland, Italy, Poland, Romania, Russia, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 15, 2011
Enrollment StartJun 1, 2011
Primary CompletionOct 1, 2013
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.0 years ago

Interventions

dasatinibdrug

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.

Placebodrug

Matching Placebo