2
Participants
Start Date
November 30, 2007
Primary Completion Date
September 30, 2009
Study Completion Date
September 30, 2009
Dasatinib
Fresh frozen tumor tissue must be available prior to initiating dasatinib. Eligible patients will receive neoadjuvant dasatinib 70 mg PO twice daily for 3 weeks followed by surgery. The surgical specimen will be evaluated for pathologic response. The second tumor sample will be obtained after 3 weeks of dasatinib therapy at the time of definitive surgical resection which will be evaluated for changes in genomic expression profiles. Patients with at least a 15% decrease or better objective response, without evidence of progression (per tumor evaluation pre-surgery) or pathologic response (as defined as ≥30% tumor necrosis or cell death) to neoadjuvant dasatinib therapy will be eligible to receive dasatinib 70 mg twice daily for 90 days after the completion of standard adjuvant therapy.
Duke University Medical Center, Durham
Lead Sponsor
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
Duke University
OTHER