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Spots Global Cancer Trial Database for LBH589 and Gemcitabine in the Treatment of Solid Tumors

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Trial Identification

Brief Title: LBH589 and Gemcitabine in the Treatment of Solid Tumors

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

Study ID: NCT00550199

Conditions

Solid Tumors

Interventions

LBH589, Gemcitabine

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Tennessee Oncology, PLLC, Nashville, Tennessee, United States

Contact Details

Name: Howard Burris, M.D.

Affiliation: SCRI Development Innovations, LLC

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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