LBH589 and Gemcitabine in the Treatment of Solid Tumors
Status:
Terminated
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
Summary
This will be a single center phase I dose escalation trial. LBH589 will be administered
orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days
1, 8, and 15 every 28 days. Dose escalation will begin at Dose Level 1. Three patients will
be enrolled at each dose level. If 1/3 patients experiences dose-limiting toxicity, the dose
level will be expanded to 6 patients. If 2/6 patients experience dose-limiting toxicity at a
specific dose level, then the previous dose level will be considered the recommended phase II
dose. Dose escalation will continue until the maximum tolerated dose is determined or until
all dose levels outlined in the protocol have been completed. A total of 10 patients will be
treated at the dose that is recommended for further phase II evaluation to further assess the
safety of the combination regimen. Toxicity assessments will be ongoing and disease
assessments will be repeated every 2 treatment cycles. Patients will be allowed to continue
on study until disease progression unless toxicity warrants drug discontinuation.