Advanced Adult Primary Liver Cancer Clinical Trial
Official title:
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.
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