CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 23 enrolled
Drug / intervention
Pevonedistat 25 mg/m^2 +4 moredrug
Likely dose
Pevonedistat 25 mg/m^2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02782468
NCT02782468Phase 1Completed
CompareCT.gov

A Phase 1/1b, Open-label Study of Pevonedistat (MLN4924, TAK-924) as Single Agent and in Combination With Azacitidine in Adult East Asian Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)

Millennium Pharmaceuticals, Inc.·interventional·Posted May 25, 2016·Updated Nov 3, 2023

In Brief

A Phase 1 clinical trial evaluating Pevonedistat 25 mg/m^2, Pevonedistat 44 mg/m^2, and 3 other interventions for Leukemia, Myeloid, Acute and Myelodysplastic Syndromes. Completed, enrolled 23 participants across 9 sites in 3 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myeloid, Acute, Myelodysplastic Syndromes
CountriesJapan, South Korea, Taiwan
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 25, 2016
Enrollment StartMay 16, 2016
Primary CompletionJan 25, 2022
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 10.1 years ago

Interventions

Pevonedistat 25 mg/m^2drug

Pevonedistat 25 mg/m\^2 intravenous infusion.

Pevonedistat 44 mg/m^2drug

Pevonedistat 44 mg/m\^2 intravenous infusion.

Pevonedistat 10 mg/m^2drug

Pevonedistat 10 mg/m\^2 intravenous infusion.

Pevonedistat 20 mg/m^2drug

Pevonedistat 20 mg/m\^2 intravenous infusion.

Azacitidine 75 mg/m^2drug

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