Phase 2 Safety, Tolerability and Efficacy Study of CPI-613 in Cancer Patients

PHASE2TerminatedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Cancer
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 the maximum tolerated dosing \[MTD\]), via a central venous catheter with D5W running at a rate of about 125-150 mL/hr.

Trial Locations (1)

10469

Eastchester Center for Cancer Care, The Bronx

Sponsors
All Listed Sponsors
lead

Cornerstone Pharmaceuticals

INDUSTRY

NCT01832857 - Phase 2 Safety, Tolerability and Efficacy Study of CPI-613 in Cancer Patients | Biotech Hunter | Biotech Hunter