drugset / Trial / NCT00598091

A Phase I/Expansion Study of Dasatinib

NCT00598091

Phase 1 Terminated 30 enrolled Duke University Bristol-Myers Squibb · collab
Non-randomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to find the highest dose of the drugs gemcitabine and dasatinib that can be given for the treatment of pancreatic cancer. Gemcitabine (also called Gemzar™)is a drug that is given intravenously. Dasatinib (also called Sprycel™) is a tablet and will be taken by mouth. Gemcitabine is approved by the Food and Drug Administration (FDA) for the treatment of advanced breast, lung and pancreatic cancer. Dasatinib is approved by the FDA for the treatment of chronic myeloid leukemia (CML), acute lymphoblastic leukemia or for patients that are resistant to imatinib mesylate (Gleevec™ ). This study will try to find the highest doses of these drugs that can be tolerated when taken in combination. The study will also look at how the drugs work in the body, and will see if there is any effect on pancreatic cancer.

Timeline

Start
2007-04
Primary completion
2010-06
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Comparator dasatinib anhydrous Small molecule 50 mg Oral