37
Participants
Start Date
September 24, 2013
Primary Completion Date
April 15, 2021
Study Completion Date
April 15, 2021
Docetaxel
75 mg/m2 IV given over 60 minutes on day 8 every 21 days (1 cycle)
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
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)
Pegfilgrastim
administered on day 9 subcutaneously at 6 mg
Hillman Cancer Center, Pittsburgh
Merck Sharp & Dohme LLC
INDUSTRY
Melissa Burgess, MD
OTHER