Study of Dasatinib in Patients with locally advanced pancreatic cancer
Research type
Research Study
Full title
Phase 2 Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects with Locally-advanced Pancreatic Cancer
IRAS ID
76333
Contact name
Thomas Ronald Jeffry Evans
Contact email
Sponsor organisation
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eudract number
2010-024595-26
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to find out the potential effectiveness and safety of adding dasatinib to gemcitabine in patients with locally advanced (inoperable) pancreatic cancer who do not have any evidence of spread to secondary sites (metastases).Dasatinib blocks the molecular pathways in cells that are implicated in the processes by which cancer cells migrate and spread to form secondary deposits (metastases). It is given as a tablet and is licensed for use in patients with Chronic Myeloid Leukaemia. Experiments in the laboratory have demonstrated that it can inhibit the development of metastases in pancreatic cancer models. Gemcitabine is a chemotherapy drug that's given as an intravenous infusion, and it is commonly used on its own in the treatment of patients with pancreatic cancer. However, it has modest benefits in patients with this disease, and better treatments are required. Previous studies have found the safe doses of gemcitabine and dasatinib to use when they are given together to patients with pancreatic cancer.This clinical study will take place at approximately 75 centres, and about 200 patients are expected to participate. These patients will have inoperable pancreatic cancer that has not spread to form metastases. Half of the patients will receive gemcitabine plus dasatinib, and half will receive gemcitabine plus a placebo (??dummy pill?Â). Treatment will be assigned randomly to patients by chance (like a coin flip), and patients will not know whether they are receiving dasatinib or placebo. Treatment may continue for as long as the patient is benefiting from the treatment.
REC name
West of Scotland REC 1
REC reference
11/AL/0322
Date of REC Opinion
22 Jul 2011
REC opinion
Further Information Favourable Opinion