A Study of Pevonedistat in Adult East Asian Participants

Phase 1 Completed 23 enrolled Millennium Pharmaceuticals, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2016-05-16
Primary completion: 2022-01-25
Completion: 2022-01-25

Publications

Handa H, Cheong JW, Onishi Y, Iida H, Kobayashi Y, Kim HJ, Chiou TJ, Izutsu K, Tsukurov O, Zhou X, Faessel H, Yuan Y, Sedarati F, Faller DV, Kimura A, Wu SJ. Pevonedistat in East Asian patients with acute myeloid leukemia or myelodysplastic syndromes: a phase 1/1b study to evaluate safety, pharmacokinetics and activity as a single agent and in combination with azacitidine. J Hematol Oncol. 2022 May 11;15(1):56. doi: 10.1186/s13045-022-01264-w.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azacitidine	Other / unclassified	75 mg/m2	Intravenous
Subject	Pevonedistat	Small molecule	10 mg/m2	Intravenous
Subject	Pevonedistat	Small molecule	20 mg/m2	Intravenous
Subject	Pevonedistat	Small molecule	25 mg/m2	Intravenous
Subject	Pevonedistat	Small molecule	44 mg/m2	Intravenous

A Study of Pevonedistat in Adult East Asian Participants

Summary

Timeline

Publications

Drugs

Indications