Last updated on June 2019

Pevonedistat and Belinostat in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome


Brief description of study

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 or does not respond to treatment. Drugs used in chemotherapy, 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.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To identify the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) for a regimen combining MLN4924 (pevonedistat) with belinostat in patients with refractory/relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

SECONDARY OBJECTIVES:

I. To describe the toxicities of this regimen. II. To observe and record anti-tumor activity. III. If responses are observed, to determine what relationship, if any, exists between such responses and TP53/FLT3 mutational status.

IV. To describe pharmacokinetic (PK) interactions, if any, between MLN4924 (pevonedistat) and belinostat.

V. To test the feasibility of performing correlative studies involving nuclear RelA, p-ATR, p-Chk1, Cdt-1, gammaH2A.X, p-BRCA1, p-FANCD2, Ac-H3K56, Ac-H4K16, BCL-2, BIM, BCL-xL, or MC-1.

OUTLINE: This is a dose-escalation study.

Patients receive belinostat intravenously (IV) once daily (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.

After completion of study treatment, patients are followed up for 30 days and then every 2 months for 2 years.

Clinical Study Identifier: NCT03772925

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Recruitment Status: Open


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