NCT03370159

CPI-613 and Docetaxel in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer

A Phase I/II Open-Label Dose Escalation Trial of CPI-613 in Combination With Docetaxel Chemotherapy as a Second-Line Treatment of Non-Small-Cell Lung Cancer

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of 6,8-bis(benzylthio)octanoic acid (CPI-613) when given together with docetaxel and to see how well they work in treating patients with stage IIIB or IV non-small cell lung cancer. Drugs used in chemotherapy, such as CPI-613 and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerate dose (MTD) of CPI-613 when used in combination with docetaxel therapy in advanced stage non-small cell lung cancer (NSCLC). (Phase1) II. To evaluate the response rate in patients receiving CPI-613 in combination with docetaxel therapy. (Phase 2) SECONDARY OBJECTIVES: I. To determine the safety of CPI-613 addition to docetaxel therapy. II. To determine the progression-free survival with CPI-613 in combination with docetaxel therapy at 27 weeks. III. To determine the median progression-free survival with CPI-613 in combination with docetaxel therapy. OUTLINE: This is a phase I, dose-escalation study of CPI-613 followed by a phase II study. Patients receive CPI-613 intravenously (IV) over 2 hours on days 1 and 3, and docetaxel IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients that achieve stable disease after 6 courses then receive CPI-613 alone on days 1and 3. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then periodically for 2 years.

Conditions

• Stage IIIB Non-Small Cell Lung Cancer AJCC v7
• Stage IV Non-Small Cell Lung Cancer AJCC v7

Interventions

Type	Name	Description
DRUG	6,8-Bis(benzylthio)octanoic Acid	Given IV
DRUG	Docetaxel	Given IV
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-03-01
• Completion: 2020-03-01
• First posted: 2017-12-12
• Last updated: 2018-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study