Clinical Trial: CPI-613 in Treating Patients With Advanced or Metastatic Bile Duct Cancer That Cannot Be Removed By Surgery
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Pilot Open-Label Clinical Trial of CPI-613 in Patients With Advanced Bile Duct Cancers
Brief Summary: 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
Detailed Summary:
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.
Sponsor: Wake Forest University Health Sciences
Current Primary Outcome: Overall survival [ Time Frame: From the first dose of 6,8-bis(benzylthio)octanoic acid to death, assessed up to 3 years ]
Original Primary Outcome: Overall Survival (OS) [ Time Frame: Day 1 ]
Current Secondary Outcome:
- Response rate defined as proportion of patients with complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), using based on the RECIST version 1.1 [ Time Frame: From the start of the treatment until DP, assessed up to 3 year ]95% confidence interval will be included.
- Progression-free survival [ Time Frame: From the first dose of 6,8-bis(benzylthio)octanoic acid to disease progression (DP) or death due to any cause, assessed up to 3 years ]Estimated using Kaplan-Meier techniques.
- Adverse events, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 [ Time Frame: Up to 1 month after completion of study treatment ]
Original Secondary Outcome:
Information By: Wake Forest University Health Sciences
Dates:
Date Received: January 10, 2013
Date Started: May 2013
Date Completion: May 2017
Last Updated: May 25, 2017
Last Verified: March 2017