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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Dasatinib; Gemcitabine

Criteria

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.