drugset / Trial / NCT00741403

A Open Label Phase I/II Clinical Trial to Evaluate CPI-613 in Patients With Advanced Malignancies

NCT00741403

Phase 1 Completed 39 enrolled Cornerstone Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

An open label, dose-escalation study to evaluate safety, tolerability, maximum tolerated dose (MTD), efficacy, and pharmacokinetics (PKs) of CPI-613 given twice weekly for three consecutive weeks in cancer patients The objectives of this study are: * To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks. * To determine pharmacokinetics of CPI-613 following intravenous (IV) administration. * To observe the anti-tumor effects of CPI-613, if any occur.

Timeline

Start
2008-08
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject CPI-613 Small molecule Intravenous