CPI-613 + Chemotherapy for Biliary Tract Cancer

Recruiting at9 trial locations

Overseen by Vaibhav Sahai, MBBS, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Michigan Rogel Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to determine the safety and efficacy of CPI-613 (devimistat) in the treatment of advanced biliary tract cancer when used in combination with standard of care chemotherapy (gemcitabine plus cisplatin) compared to gemcitabine plus cisplatin alone. This research study has two parts: In the phase 1 portion of this study, patients will receive a combination of CPI-613 and standard of care chemotherapy. Dose levels of CPI-613 will be adjusted to find the best dose, which will be the recommended phase 2 dose level. In the phase 2 portion of this study, patients will be randomized into two arms. Patients in Arm A will receive the combination of the recommended dose level of CPI-613 and standard of care chemotherapy. Patients in Arm B will receive standard of care chemotherapy. At the end of the study, researchers will compare the health outcomes of the patients that received CPI-613 + standard care to the outcomes of patients that received only standard care.

Research Team

Vaibhav Sahai, MBBS, MS

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

This trial is for adults with advanced biliary tract cancer that can't be removed by surgery. They should have measurable disease, no prior systemic treatment for this cancer, and must not have had major surgery or uncontrolled infections recently. Participants need to agree to use two forms of contraception and cannot be pregnant or breastfeeding.

Inclusion Criteria

I am 18 years old or older.

I have a tumor that can be measured on scans and hasn't been treated with radiation or specific liver therapies.

Ability to understand and willingness to sign IRB-approved informed consent.

Exclusion Criteria

I had major surgery less than 4 weeks ago.

I am not pregnant or breastfeeding and have a negative pregnancy test if of childbearing age.

You are allergic to cisplatin, gemcitabine, or CPI-613.

Treatment Details

Interventions

• Cisplatin (Alkylating Agent)
• CPI-613 (Mitochondrial Metabolism Inhibitor)
• Gemcitabine (Anti-metabolite)

Trial Overview Researchers are testing the safety and effectiveness of CPI-613 (devimistat) combined with standard chemotherapy (gemcitabine plus cisplatin) versus just the chemotherapy alone. The study has two parts: finding the best dose of CPI-613 in phase 1, then comparing health outcomes between the two treatments in phase 2.

Participant Groups

Group I: Phase 1 and Phase 2, Arm A (investigational) Experimental Treatment 3 Interventions

On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.

Group II: Phase 2, Arm B (standard of care) Active Control 2 Interventions

On Day 1 and Day 8 of each 3-week cycle, patients will receive gemcitabine and cisplatin. Patients may continue gemcitabine and cisplatin for up to 2 years in absence of disease progression or unacceptable toxicity.

Cisplatin is already approved in Canada, Japan for the following indications:

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Marschall S. Runge

University of Michigan Rogel Cancer Center

Chief Executive Officer since 2015

MD, PhD

Eric R. Fearon

University of Michigan Rogel Cancer Center

Chief Medical Officer since 2016

MD, PhD