CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 64 enrolled
Drug / intervention
MLN4924 +1 moredrug
Likely dose
Not stated in 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/NCT01814826
NCT01814826Phase 1Completed
CompareCT.gov

A Phase 1b, Open-Label, Dose-Escalation Study of MLN4924 Plus Azacitidine in Treatment-Naïve Patients With Acute Myelogenous Leukemia Who Are 60 Years or Older

Millennium Pharmaceuticals, Inc.·interventional·Posted Mar 20, 2013·Updated Mar 3, 2020

In Brief

A Phase 1 clinical trial evaluating MLN4924 and Azacitidine for Acute Myelogenous Leukemia. Completed, enrolled 64 participants across 8 sites.

Detailed Summary

The purpose of this study is to establish the maximum tolerated dose (MTD), and to assess the safety and tolerability of MLN4924 (pevonedistat) in combination with azacitidine in treatment naive participants with AML who were 60 years of age or older.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myelogenous Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 20, 2013
Enrollment StartApr 10, 2013
Primary CompletionMay 3, 2016
Study CompletionApr 8, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 13.3 years ago

Interventions

MLN4924drug

MLN4924 intravenously (IV) in AML participants in a 28-day cycle: * MLN4924 on Days 1, 3, and 5 for Cycle 1 and all subsequent cycles

Azacitidinedrug

Azacitidine (IV) or subcutaneously in AML participants in a 28-day cycle: \- Azacitidine Days 1, 2, 3, 4, 5, 8, 9 in Cycle 1 and for all subsequent cycles