Phase I Study of Cetuximan Plus Dasatinib (BMS-354825) in Advanced Solid Malignancies
This is an open-label, phase I study of cetuximab and differing dose levels of dasatinib in
adult patients with advanced solid malignancies. Cetuximab will be administered as an
intravenous infusion on a standard dose and schedule (weekly, with the first dose at 400
mg/m2 and all subsequent weekly doses at 250 mg/m2). Dasatinib will be administered orally
on a continuous schedule at the following dose levels: 100 mg QD (once a day), 150 mg QD,
and 200 mg QD. Three to six patients will be enrolled at each dose level, and the final
recommended phase II cohort will be expanded to include up to 12 additional patients. The
doses will be escalated in successive cohorts of patients. On cycle 1, dasatinib
administration will start one day prior to cetuximab administration. One cycle will be
defined as 21 days, and cycles will continue until progression of disease or intolerable
toxicities occur. Peripheral blood samples and pharmacokinetic blood samples will be taken
on days 0, 1, 15, and 16 of Cycle 1 only. In patients with accessible tumor that give
consent, patients will undergo a baseline tumor biopsy and a repeat biopsy after 14-21 days
of the first cycle.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the toxicities and the maximum tolerated doses of dasatinib when combined with cetuximab for the treatment of advanced solid tumors
Anticipated completion date December 2008
Yes
Edward Chu, MD
Principal Investigator
University of Pittsburgh
United States: Institutional Review Board
06-038
NCT00388427
June 2007
December 2012
Name | Location |
---|---|
University of Pittsburgh Cancer Institute - Hillman Cancer Center | Pittsburgh, Pennsylvania 15232 |