Pevonedistat + Chemotherapy for Bile Duct Cancer

Recruiting in Palo Alto (17 mi)

+505 other locations

Overseen byDustin A Deming

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well pevonedistat alone or in combination with chemotherapy (paclitaxel and carboplatin) works in treating patients with bile duct cancer of the liver. Pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as paclitaxel and carboplatin, 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. This study may help the study doctors find out how well pevonedistat shrinks bile duct cancer of the liver when given alone and when in combination with paclitaxel and carboplatin.

Eligibility Criteria

Adults with advanced bile duct cancer of the liver, who have tried one chemotherapy regimen without success, can join this trial. They should be in good physical condition (ECOG 0-1), expect to live at least 12 weeks, and have measurable disease. Those with HIV or hepatitis must meet specific criteria. People cannot participate if they're planning surgery soon, are pregnant or breastfeeding, haven't recovered from previous treatments' side effects (except hair loss), or have certain heart conditions.

Inclusion Criteria

I have someone legally authorized to make decisions for me due to my impaired decision-making capacity.

I am HIV positive with a CD4 count >= 350, undetectable viral load, on modern HIV meds without ritonavir, and no AIDS-defining infections.

I have a specific liver cancer that has spread or can't be removed and didn't respond well to my first chemotherapy.

+25 more

Exclusion Criteria

As part of enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if a new medication need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product

I have not had major surgery in the last 14 days.

I am taking medication that affects liver enzymes.

+27 more

Participant Groups

The trial is testing Pevonedistat alone and combined with chemotherapy drugs Paclitaxel and Carboplatin for treating liver bile duct cancer. The goal is to see how well these treatments shrink the cancer compared to current methods.

2Treatment groups

Experimental Treatment

Group I: Arm B (pevonedistat, paclitaxel, carboplatin)Experimental Treatment3 Interventions

Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician.

Group II: Arm A (pevonedistat)Experimental Treatment1 Intervention

Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: