NCT00474812

Dasatinib in Treating Patients With Metastatic Pancreatic Cancer

Phase II Study of Dasatinib (BMS-354825) in Patients With Metastatic Adenocarcinoma of the Pancreas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with metastatic pancreatic cancer.

Detailed description

PRIMARY OBJECTIVE: I. Determine the overall survival, including median survival, of patients with metastatic adenocarcinoma of the pancreas treated with dasatinib. SECONDARY OBJECTIVES: I. Determine the effects of this drug on quantities of circulating tumor cells in these patients. 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.

Conditions

• Adenocarcinoma of the Pancreas
• Recurrent Pancreatic Cancer
• Stage IV Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	dasatinib
PROCEDURE	laboratory biomarker analysis	Correlative study
PROCEDURE	physiologic testing	Correlative study

Timeline

• Start date: 2007-05-01
• Primary completion: 2013-01-01
• Completion: 2014-02-01
• First posted: 2007-05-17
• Last updated: 2015-05-05
• Results posted: 2013-12-23

Locations

1 site across 1 country: United States