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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

September 24, 2013

Primary Completion Date

April 15, 2021

Study Completion Date

April 15, 2021

Conditions
Sarcoma
Interventions
DRUG

Docetaxel

75 mg/m2 IV given over 60 minutes on day 8 every 21 days (1 cycle)

DRUG

Gemcitabine

given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle). For dose level -2, given over 67.5 minutes at 10 mg/m2/min

DRUG

Vorinostat

given orally at the specified dose levels (either 300 mg/daily or 200 mg twice per day) on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle)

DRUG

Pegfilgrastim

administered on day 9 subcutaneously at 6 mg

Trial Locations (1)

15232

Hillman Cancer Center, Pittsburgh

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Melissa Burgess, MD

OTHER

NCT01879085 - Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma | Biotech Hunter | Biotech Hunter