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

2014-08-27 03:21:56 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cancer

Intervention

CPI-613, CPI-613, Gemcitabine, Gemcitabine, Gemcitabine

Location

Eastchester Center for Cancer Care
Bronx
New York
United States
10469

Status

Recruiting

Source

Cornerstone Pharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:21:56-0400

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