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



Status:Archived
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:May 2009
End Date:May 2011

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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.


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.


We found this trial at
2
sites
Honolulu, Hawaii 96814
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