Clinical Trial: CPI-613 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Pilot Study: Open-Label Clinical Trial of CPI-613 in Patients With Metastatic Pancreatic Adenocarcinoma and Poor Performance Status

Brief Summary: This pilot clinical trial studies 6,8-bis(benzylthio)octanoic acid in treating patients with locally advanced or metastatic pancreatic cancer. Drugs used in chemotherapy, such as 6,8-bis(benzylthio)octanoic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine initial estimates of overall survival (OS).

SECONDARY OBJECTIVES:

I. To determine response rate. II. To determine progression free survival (PFS).

OUTLINE:

Patients receive 6,8-bis(benzylthio)octanoic acid intravenously (IV) over 2 hours on days 1-5 of week 1 (pre-course 1 only), days 1 and 4 of weeks 2 and 3 (course 1 only), and days 1 and 4 of weeks 1-3 (courses 2-6). Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.


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 ]

Survival curves for OS will be estimated using Kaplan-Meier techniques.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Response rate [ Time Frame: Up to 3 years ]
    The proportion of patients who are complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be presented. The proportion of responders will be estimated as the percent of patients who are CR or PR. A 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 ]
    Survival curves for PFS will be estimated using Kaplan-Meier techniques.
  • Safety profile assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 3 years ]


Original Secondary Outcome: Same as current

Information By: Wake Forest University Health Sciences

Dates:
Date Received: April 23, 2013
Date Started: July 2013
Date Completion:
Last Updated: March 13, 2017
Last Verified: March 2017