Pevonedistat, Azacitidine (or Decitabine), and Venetoclax for the Treatment of Patients With Acute Myelogenous Leukemia

NCT04172844 ↗

Phase 1 Terminated 16 enrolled Medical College of Wisconsin

Non-randomizedSequentialOpen-labelTreatment

Summary

This is a phase Ib study with a 3 + 3 dose escalation design followed by a dose-expansion phase.

Timeline

Start: 2020-01-13
Primary completion: 2021-12-12
Completion: 2022-02-27

Outcome

Outcome not reported

Stopped: “Takeda P3001 study didn't meet primary endpoint of improvement in event-free survival. There is no regulatory path forward for pevonedistat.”

Publications

Murthy GSG, Saliba AN, Szabo A, Harrington A, Abedin S, Carlson K, Michaelis L, Runaas L, Baim A, Hinman A, Maldonado-Schmidt S, Venkatachalam A, Flatten KS, Peterson KL, Schneider PA, Litzow M, Kaufmann SH, Atallah E. A phase I study of pevonedistat, azacitidine, and venetoclax in patients with relapsed/refractory acute myeloid leukemia. Haematologica. 2024 Sep 1;109(9):2864-2872. doi: 10.3324/haematol.2024.285014.

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	15 mg/m2	Intravenous
Subject	Pevonedistat	Small molecule	20 mg/m2	Intravenous
Subject	Venetoclax	Small molecule	400 mg	Oral