Safety and Effectiveness Study of CPI-613 and/or Gemcitabine to Treat Metastatic Pancreatic Cancer

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 31, 2014

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2018

Conditions
Metastatic Pancreatic Adenocarcinoma
Interventions
DRUG

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.

DRUG

Gemcitabine

DRUG

Any non-gemcitabine chemotherapies or best supportive care

Trial Locations (2)

10469

Eastchester Center for Cancer Care, The Bronx

76508

Temple Vasicek Cancer Treatment Center, Temple

Sponsors
All Listed Sponsors
lead

Cornerstone Pharmaceuticals

INDUSTRY

NCT01830322 - Safety and Effectiveness Study of CPI-613 and/or Gemcitabine to Treat Metastatic Pancreatic Cancer | Biotech Hunter | Biotech Hunter