Spots Global Cancer Trial Database for A Phase I/II Open-Label Dose-Escalation Clinical Trial of CPI-613 in Combination With Gemcitabine in Cancer Patients
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Trial Identification
Brief Title: A Phase I/II Open-Label Dose-Escalation Clinical Trial of CPI-613 in Combination With Gemcitabine in Cancer Patients
Official Title: A Phase I/II Open-Label Dose-Escalation Clinical Trial of CPI-613 in Combination With Gemcitabine in Cancer Patients
Study ID: NCT00907166
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Eastchester Center for Cancer Care, Bronx, New York, United States
Mary Crowley Cancer Research Centers, Dallas, Texas, United States
Contact Details
Name: Avi Retter, M.D.
Affiliation: Eastchester Center for Cancer Care
Role: PRINCIPAL_INVESTIGATOR
Name: Neil Senzer, M.D.
Affiliation: Mary Crowley Cancer Research Centers
Role: PRINCIPAL_INVESTIGATOR
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