NCT01814826

Study of MLN4924 Plus Azacitidine in Treatment-naive Participants With Acute Myelogenous Leukemia (AML) Who Are 60 Years or Older

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	MLN4924	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
DRUG	Azacitidine	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

Timeline

• Start date: 2013-04-10
• Primary completion: 2016-05-03
• Completion: 2018-04-08
• First posted: 2013-03-20
• Last updated: 2020-03-03
• Results posted: 2020-03-03

Locations

8 sites across 1 country: United States