Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatment dasatinib
Phase phase 2
Target BCR-ABL
Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date June 2011
End date October 2014
Trial size 200 participants
Trial identifier NCT01395017, 287-11-201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
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).
dasatinib BMS-354825
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.
(Placebo Comparator)
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).
dasatinib BMS-354825
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.

Primary Outcomes

Measure
The primary efficacy endpoint is overall survival.
time frame: Participants will be followed for the duration of the study, the participants will be contacted monthly for an expected average of 12-16 months to collect survival data after study discontinution.

Secondary Outcomes

Measure
Progression free survival (PFS)
time frame: Subjects will be assessed by imaging after every 2 cycles (ie, Weeks 8, 16, 24, etc.).

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologic or cytologic documentation of unresectable adenocarcinoma of the pancreas. - Recovery from toxicity of previous procedures to establish the diagnosis. ECOG PS 0 or 1. - Adequate organ function. Exclusion Criteria: - Evidence of metastatic disease. - Previous radiotherapy or chemoradiotherapy. - History of or current pleural effusion. - History of significant cardiovascular disease. - Clinically significant bleeding disorder or coagulopathy. - Concomitant medication with strong CYP 3A4 inhibitor.

Additional Information

Official title Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc..