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Alkylating agent

Pevonedistat + Chemotherapy for Bile Duct Cancer

Phase 2

Waitlist Available

Led By Dustin A Deming

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Known HIV positive patients who meet the following criteria will be considered eligible: CD4 count >= 350 cells/mm^3, Undetectable viral load, Maintained on modern therapeutic regimens utilizing non-CYP interactive agents (i.e. excluding ritonavir), No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections

Patient must have histologically confirmed intrahepatic cholangiocarcinoma or biphasic hepatocellular carcinoma and cholangiocarcinoma that is metastatic or unresectable and who have progressed on or been intolerant of one prior line of systemic gemcitabine containing chemotherapy regimen

Must not have

Patients must not have had major surgery within 14 days before randomization

Prior treatment with radiation therapy involving >= 25% of hematopoietically active bone marrow will be ineligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies if a drug & chemo combo can shrink bile duct cancer of the liver. The drug blocks enzymes needed for cell growth & chemo kills/stops cell growth/spreading.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Pevonedistat may cause cell growth inhibition side effects; Paclitaxel and Carboplatin could lead to typical chemo side effects like nausea, fatigue, low blood counts leading to infection risk, nerve damage causing numbness or pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I do not have serious heart or lung conditions.

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I have previously received platinum or taxane chemotherapy.

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I am being treated for HCV and my viral load is undetectable.

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I am 18 years old or older.

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I had hepatitis C but have been treated and cured.

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My kidney function tests are within normal limits or my GFR is 40 or above.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My hepatitis B virus load is undetectable with treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have not had radiation on more than 25% of my bone marrow.

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I do not have any severe or uncontrolled infections.

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I have never been treated with pevonedistat.

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I haven't had severe diarrhea for more than 3 days in the last 14 weeks.

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I am using or willing to use effective birth control or abstain from sex during and for 4 months after the study.

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I have not had immunotherapy in the last 8 weeks.

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My cancer has not spread to my brain or spinal cord.

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I am not taking any strong medication for metabolism during the study.

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I do not have any uncontrolled bleeding disorders.

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I do not have any surgeries planned during the study period.

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I am a woman who could potentially become pregnant.

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I am not taking any strong medication for epilepsy, infections, or using St. John's wort.

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I have no allergies to pevonedistat, carboplatin, or paclitaxel.

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I do not have moderate COPD, interstitial lung disease, or pulmonary fibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate

Other study objectives

Overexpression of NEDD8, NAE1, and UBC12

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Paclitaxel

2011

Completed Phase 4

~5370