Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer
Both
Pancreatic Cancer
Trial Information
Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
The primary efficacy endpoint is overall survival.
Outcome Time Frame:
Participants will be followed for the duration of the study, the participants will be contacted monthly for an expected average of 12-16 months to collect survival data after study discontinution.
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
287-11-201
NCT ID:
NCT01395017
Start Date:
June 2011
Completion Date:
August 2014
Related Keywords:
- Pancreatic Cancer
- Pancreatic cancer
- Dasatinib
- chemotherapy
- Locally advanced
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Alexandria, Minnesota 56308 | |
| Albany, Georgia 31701 | |
| Birmingham, Alabama 35294 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Albany, New York 12208 | |
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| Kansas City, Kansas 66160 | |
| Omaha, Nebraska 68114 | |
| Albuquerque, New Mexico 87131-5636 | |
| Denver, Colorado |
