NCT00907166

A Phase I/II Open-Label Dose-Escalation Clinical Trial of CPI-613 in Combination With Gemcitabine in Cancer Patients

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Cornerstone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are: * To determine the safety and MTD of CPI-613, when used in combination with Gemcitabine, in cancer patients. * To compare the safety and efficacy of CPI-613/Gemcitabine combination vs. Gemcitabine alone in patients with carcinoma of the pancreas.

Detailed description

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.

Conditions

• Cancer
• Pancreatic Cancer
• Pancreatic Carcinoma

Interventions

Type	Name	Description
DRUG	CPI-613	IV infusion of CPI-613 given on Days 1,4, 8, 11, 15, 18, of 28 day cycle in cancer patients.
DRUG	CPI-613	IV infusion of CPI-613 given on Days 1, 4, 8, 11, 15, 18, of 28 day cycle in patients with pancreatic carcinoma.
DRUG	Gemcitabine	IV infusion of 1000 mg/m\^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in patients with pancreatic carcinoma.
DRUG	Gemcitabine	IV infusion of 1000 mg/m\^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in cancer patients.
DRUG	Gemcitabine	IV infusion of 1000 mg/m\^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in patients with pancreatic carcinoma.

Timeline

• Start date: 2009-05-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2009-05-22
• Last updated: 2017-03-21

Locations

2 sites across 1 country: United States