NCT01839981

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (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 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 description

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.

Conditions

• Acinar Cell Adenocarcinoma of the Pancreas
• Duct Cell Adenocarcinoma of the Pancreas
• Recurrent Pancreatic Cancer
• Stage III Pancreatic Cancer
• Stage IV Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	6,8-bis(benzylthio)octanoic acid	Given IV

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-04-25
• Last updated: 2018-12-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study