A Study of Pevonedistat in Combination With Azacitidine in Participants With Higher-risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myelogenous Leukemia (AML) With Severe Renal Impairment or Mild Hepatic Impairmen | Aplastic Anemia & MDS International Foundation
A Study of Pevonedistat in Combination With Azacitidine in Participants With Higher-risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myelogenous Leukemia (AML) With Severe Renal Impairment or Mild Hepatic Impairmen

Clinical Trial: NCT03814005

For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

The drug being tested in this study is called pevonedistat. The study will characterize the PK of pevonedistat, assess the safety, and determine the dose of pevonedistat, in combination with azacitidine, in participants with myelodysplastic syndromes (MDS), CMML and AML who also have severe renal impairment or mild hepatic impairment.

The study will enroll approximately 60 participants. The study will be conducted in 2 parts: Part A (PK run-in and dose escalation phase) and Part B. In Part A, participants will be assigned to one of the 3 treatment groups on the basis of their renal and hepatic function:

  • Control Arm (Normal Renal and Hepatic Function)
  • Renal Arm (Severe Renal Impairment)
  • Hepatic Arm (Mild Hepatic Impairment)

Part A will include pevonedistat PK run-in starting on Day -7, followed by a dose-escalation phase with the combination of pevonedistat and azacitidine starting on Day 1. Eligible participants from Part A will continue treatment in optional Part B with the same treatment received in Part A: pevonedistat in combination with azacitidine.

This multi-center trial will be conducted in the United States and Spain. The overall time to participate in this study is approximately 2.5 years. Participants will attend end of the study visit 30 days after the last dose of study drug or before the start of subsequent therapy, if that occurs sooner for safety follow up.

Status: 
Recruiting
Study Date: 
Wed, 01/23/2019 to Wed, 10/06/2021
Bone Marrow Disease(s): 
  • acute myeloid leukemia (AML)
  • chronic myelomonocytic leukaemia (CMML)
  • myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: Azacitidine Azacitidine subcutaneous injection. Drug: Pevonedistat Pevonedistat intravenous infusion. Other Name: TAK-924 and MLN4924