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Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma — GemTax  

Sarcoma Clinical Trial

Official title:
Phase 1b/2 Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma

Clinical Trial Summary

This is a Phase Ib/II experimental, open-label, dose escalation, active treatment study designed to determine the safety, tolerability, and recommended dose of the combination. During the Phase 2 portion of the study, we will assess progression-free survival (PFS), overall survival (OS),overall response rate (ORR), correlative endpoints, DNA methylation measured by microarray, and expression level of the genes as measured by microarray

Clinical Trial Description

Phase 1b - To determine the dose of vorinostat that can be safely combined with gemcitabine and docetaxel in patients with advanced sarcomas. - To characterize the Pharmacokinetics (PK) and Pharmacodynamics (PD) of vorinostat when combined with gemcitabine and docetaxel in patients with advanced sarcomas (Exploratory Aim). Phase 2 - To determine the safety and efficacy of gemcitabine and docetaxel in combination with vorinostat in patients with advanced sarcomas. The hypothesis is that gemcitabine and docetaxel + vorinostat will be safe and will improve the 6-months progression-free rates (PFR) of the combination by 20% (from 20% to 40%). - To determine the objective response rate, progression-free, and overall survival of patients with advanced sarcomas treated with gemcitabine and docetaxel + vorinostat; - To develop a predictive molecular signature of response to treatment in advanced sarcomas. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01879085
Study type Interventional
Source University of Pittsburgh
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 24, 2013
Completion date April 15, 2021
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