Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Panobinostat

Antimetabolites

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Phase I dose escalation: LBH589 will be administered orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days 1, 8, and 15 every 28 days.

LBH589, Gemcitabine

Howard Burris, M.D.

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.

LBH589 and Gemcitabine in the Treatment of Solid Tumors

A Phase I Study of LBH589 in Combination With Gemcitabine in the Treatment of Solid Tumors

Novartis

SCRI Development Innovations, LLC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
LBH589 and Gemcitabine in the Treatment of Solid Tumors	NCT00550199	Solid Tumors	LBH589, Gemcita...	18 Years -	SCRI Development Innovations, LLC
LBH589 and Gemcitabine in the Treatment of Solid Tumors	NCT00550199	Solid Tumors	LBH589, Gemcita...	18 Years -	SCRI Development Innovations, LLC

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