Phase II Study of Dasatinib (BMS-354825) in Patients With Metastatic Adenocarcinoma of the Pancreas
I. Determine the overall survival, including median survival, of patients with metastatic
adenocarcinoma of the pancreas treated with dasatinib.
I. Determine the effects of this drug on quantities of circulating tumor cells in these
II. Determine the time to progression in patients treated with this drug. III. Determine
pre- and post-drug fat-free mass and gait speed in patients treated with this drug.
IV. Evaluate the toxicity of this drug in these patients. V. Evaluate objective response
rate in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in
the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection at baseline and during days 25-31. Samples are analyzed
for quantification of circulating tumor cells. Patients also undergo analysis of fat-free
mass and gait speed at baseline and at 1, 2, and 6 months.
After completion of study treatment, patients are followed periodically.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Median overall survival
The probability of overall survival will be estimated by Kaplan-Meier method. The estimated median survival will be compared to those reported in the literature.
From the date of onset of treatment to the date of death and to the date of last follow-up for those still alive, assessed up to 24 months
Case Western Reserve University
United States: Food and Drug Administration
|Case Western Reserve University||Cleveland, Ohio 44106|