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A Pilot Open-Label Clinical Trial of CPI-613 in Patients With Advanced Bile Duct Cancers
This pilot clinical trial studies 6,8-bis(benzylthio)octanoic acid in treating patients with advanced or metastatic cholangiocarcinoma that cannot be removed by surgery. 6,8-Bis(benzylthio)octanoic acid may stop the growth of cholangiocarcinoma by blocking blood flow to the tumor
PRIMARY OBJECTIVES: I. To evaluate the safety and efficacy of CPI-613 (6,8-bis\[benzylthio\]octanoic acid) in patients with advanced unresectable cholangiocarcinoma who have failed available therapies. OUTLINE: Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid intravenously (IV) over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. After completion of study treatment, patients are followed up bimonthly.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Start Date
May 1, 2013
Primary Completion Date
April 1, 2018
Completion Date
May 18, 2018
Last Updated
May 15, 2019
17
ACTUAL participants
6,8-bis(benzylthio)octanoic acid
DRUG
Lead Sponsor
Wake Forest University Health Sciences
Collaborators
NCT01730937
NCT02088775
Data Source & Attribution
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