NCT04075747

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

V-FAST: A Phase 1b Master Trial to Investigate CPX-351 Combined With Various Targeted Agents in Subjects With Previously Untreated Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	CPX-351	Up to 2 induction and 2 consolidation courses will be offered
DRUG	Venetoclax	Will be administered over specified duration during induction and consolidation courses
DRUG	Midostaurin	Will be administered over specified duration during induction and consolidation courses
DRUG	Enasidenib	Will be administered over specified duration during induction and consolidation courses

Timeline

• Start date: 2019-12-02
• Primary completion: 2022-02-07
• Completion: 2023-09-12
• First posted: 2019-09-03
• Last updated: 2023-10-16

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study