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Brief Title: A Open Label Phase I/II Clinical Trial to Evaluate CPI-613 in Patients With Advanced Malignancies
Official Title: 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
Study ID: NCT00741403
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Pivotal Research Centers, Peoria, Arizona, United States
Eastchester Center for Cancer Care, Bronx, New York, United States
Mary Crowley Cancer Research Centers, Dallas, Texas, United States
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
Name: Karen Gelmon, M.D.
Affiliation: British Columbia Cancer Agency
Role: PRINCIPAL_INVESTIGATOR
Name: Avi Retter, M.D.
Affiliation: Eastchester Center for Cancer Care
Role: PRINCIPAL_INVESTIGATOR
Name: Divis K Khaira, M.D.
Affiliation: Pivotal Research Centers
Role: PRINCIPAL_INVESTIGATOR
Name: Senzer Neil, M.D.
Affiliation: Mary Crowley Cancer Research Centers
Role: PRINCIPAL_INVESTIGATOR