Pevonedistat + Belinostat for Acute Myeloid Leukemia or Myelodysplastic Syndrome

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byKeri R Maher

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial studies side effects and best dose of pevonedistat and belinostat in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back (relapsed) or does not respond to treatment (refractory). Chemotherapy drugs, such as pevonedistat and belinostat, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Eligibility Criteria

This trial is for adults with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), who have tried at least one treatment before. They should not have a history of certain diseases, like AIDS or active hepatitis, and must be generally healthy with an ECOG performance status of <=2. Participants need to use effective contraception and understand the study's consent.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

My chronic hepatitis B is under control with undetectable viral load.

Your bilirubin levels should be within the normal range unless you have Gilbert's syndrome. If you have Gilbert's syndrome, your direct bilirubin levels should not be more than 1.5 times the upper limit of normal for the laboratory.

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Exclusion Criteria

I have a diagnosed heart condition known as long QT syndrome.

Ventricular rate < 50 bpm or > 120 bpm

I will not donate sperm during the study or for 4 months after the last dose.

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Treatment Details

Interventions

Belinostat (Histone deacetylase inhibitor)
Pevonedistat (NEDD8-activating enzyme inhibitor)

Trial OverviewThe trial is testing the combination of two chemotherapy drugs, Pevonedistat and Belinostat, to determine their safety and optimal dosages in patients whose AML or MDS has returned after treatment or did not respond to previous treatments.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (belinostat, pevonedistat)Experimental Treatment2 Interventions

Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Belinostat is already approved in United States for the following indications:

🇺🇸 Approved in United States as Beleodaq for: