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A Study of Pevonedistat in Adult East Asian Participants

NCT02782468 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-11-03

Study results available
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Summary

The purpose of this study is to evaluate the safety and tolerability of pevonedistat administered as a single agent and in combination with azacitidine in adult east Asian participants with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS).

Conditions

Interventions

DRUG

Pevonedistat 25 mg/m^2

Pevonedistat 25 mg/m\^2 intravenous infusion.

DRUG

Pevonedistat 44 mg/m^2

Pevonedistat 44 mg/m\^2 intravenous infusion.

DRUG

Pevonedistat 10 mg/m^2

Pevonedistat 10 mg/m\^2 intravenous infusion.

DRUG

Pevonedistat 20 mg/m^2

Pevonedistat 20 mg/m\^2 intravenous infusion.

DRUG

Azacitidine 75 mg/m^2

Azacitidine 75 mg/m\^2 intravenous or subcutaneous formulation.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-16
Primary Completion
2022-01-25
Completion
2022-01-25
FDA Drug
Yes

Countries

  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02782468 on ClinicalTrials.gov