NCT00911066

MLN4924 for the Treatment of Acute Myelogenous Leukemia, Myelodysplastic Syndrome, and Acute Lymphoblastic Leukemia

An Open-Label, Dose Escalation, Phase 1 Study of MLN4924, a Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients With Acute Myelogenous Leukemia,Myelodysplastic Syndrome, and Acute Lymphoblastic Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label, multicenter, phase 1, dose escalation study of MLN4924 in adult patients with acute myelogenous leukemia (AML), high-grade myelodysplastic syndrome (MDS). The patient population will consist of adults previously diagnosed with AML including high-grade MDS for which standard curative, life-prolonging treatment does not exist or is no longer effective.

Conditions

• Acute Myelogenous Leukemia
• Acute Lymphoblastic Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	MLN4924	MLN4924 intravenous (IV) on a 21-day cycle on one of the following schedules: * Days 1, 3, and 5, followed by a rest period of 16 days (Schedule A) * Days 1, 4, 8, and 11, followed by a rest period of 10 days (Schedule B) * Continuous weekly dosing on Days 1, 8, and 15 (Schedule C) * Days 1, 4, 11, 15 for Cycle 1 only; Days 1, 4, 8, 11 for all subsequent cycles (Schedule D) * Dosing on Days 1, 3, and 5 in patients with high-grade MDS or AML (Schedule E)
DRUG	Azacitidine	Azacitidine will be administered (IV or subcutaneous (SC)) on Days 8 to 12 and Days 15 and 16 in Cycle 1, and on Days 1 to 5 and Days 8 to 9 (Schedule D)

Timeline

• Start date: 2009-06-01
• Primary completion: 2013-08-01
• Completion: 2013-10-01
• First posted: 2009-06-01
• Last updated: 2013-12-05

Locations

6 sites across 1 country: United States