NCT00741403

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Cornerstone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Cancer
• Metastatic Cancer
• Lymphoma
• Solid Tumors
• Advanced Malignancies

Interventions

Type	Name	Description
DRUG	CPI-613	CPI-613, the investigational drug, is a novel anti-tumor compound believed to operate via a novel mechanism of action that does not belong to any existing pharmacological class of anticancer agents currently being used in the clinics. Specifically, CPI-613 is Cornerstone Pharmaceutical Inc.'s lead drug from its Altered Energy Metabolism-Directed (AEMD) technology platform. It is selective against tumor cells (but not normal cells)according to preclinical studies

Timeline

• Start date: 2008-08-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2008-08-26
• Last updated: 2016-12-29

Locations

4 sites across 2 countries: United States, Canada