Phase 1b/2 Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma
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.
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
For phase 1 portion: To determine the safety, tolerability, and Phase 2 recommended dose (RP2D) of the combination.
To determine the dose of vorinostat that can be safely combined with gemcitabine and docetaxel in patients with advanced sarcomas
5 years or until disease progression/survival
Yes
Hussein Tawbi, MD
Principal Investigator
University of Pittsburgh
United States: Food and Drug Administration
UPCI# 12-104
NCT01879085
June 2013
December 2020
Name | Location |
---|---|
Hillman Cancer Center | Pittsburg, Pennsylvania 15232 |