Clinical Trials Directory

Trials / Completed

CompletedNCT01766219

CPI-613 in Treating Patients With Advanced or Metastatic Bile Duct Cancer That Cannot Be Removed By Surgery

A Pilot Open-Label Clinical Trial of CPI-613 in Patients With Advanced Bile Duct Cancers

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
17 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
DRUG6,8-bis(benzylthio)octanoic acidGiven IV

Timeline

Start date
2013-05-01
Primary completion
2018-04-01
Completion
2018-05-18
First posted
2013-01-11
Last updated
2019-05-15
Results posted
2019-05-15

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT01766219. Inclusion in this directory is not an endorsement.