Start Date
January 31, 2014
Primary Completion Date
December 31, 2018
Study Completion Date
December 31, 2018
CPI-613
CPI-613 drug product, provided in concentrated form at 50 mg/mL, must be diluted with D5W prior to administration. CPI-613 is to be infused intravenously (IV) via a central venous catheter. CPI-613 will be given 2x weekly, administered on Days 1 and 4 of each of the 3 treatment weeks, followed by a week of rest. The dose of CPI-613 will be 3,000 mg/m2 infused IV over 2 hours (this is approximate maximum tolerated dosing \[MTD\]), via a central venous catheter with D5W running at a rate of about 125-150 mL/hr.
Gemcitabine
Any non-gemcitabine chemotherapies or best supportive care
Eastchester Center for Cancer Care, The Bronx
Temple Vasicek Cancer Treatment Center, Temple
Lead Sponsor
Cornerstone Pharmaceuticals
INDUSTRY