A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia

Phase 1 Completed 57 enrolled Jazz Pharmaceuticals

Non-randomizedParallel-groupOpen-labelTreatment

Summary

JZP025-101 is an open-label, multicenter, multi-arm, nonrandomized phase 1b master trial to determine the recommended phase 2 dose (RP2D) of CPX-351 when administered in combination with various targeted agents in previously untreated subjects with Acute Myeloid Leukemia (AML) who are fit to receive intensive chemotherapy (ICT). Subjects will be assigned to treatment arms based on results of AML mutation testing.

Timeline

Start: 2019-12-02
Primary completion: 2022-02-07
Completion: 2023-09-12

Publications

Pullarkat VA, Levis M, McCloskey J, Mannis GN, Strickland SA, Fathi AT, Lin TL, Bhatt VR, Vanniyasingam T, Chakravarthy D, Lutska Y, Faderl S, Cheung RS, Erba HP. V-FAST: a phase 1b master trial to investigate CPX-351 combined with targeted agents in adults with newly diagnosed AML. Blood Neoplasia. 2025 Jun 3;2(4):100123. doi: 10.1016/j.bneo.2025.100123. eCollection 2025 Nov.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CPX-351	Other / unclassified	44 mg/m2	—
Subject	CPX-351	Other / unclassified	100 mg/m2	—
Subject	Enasidenib	Small molecule	—	—
Subject	Midostaurin	Small molecule	50 mg	—
Subject	Venetoclax	Small molecule	400 mg	—

A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia

Summary

Timeline

Publications

Drugs

Indications