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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT04075747

Public ClinicalTrials.gov record NCT04075747. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 4:30 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04075747
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Jazz Pharmaceuticals
Industry
Enrollment
57 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 1, 2019
Primary completion
Feb 6, 2022
Completion
Sep 11, 2023
Last update posted
Oct 15, 2023

2019 – 2023

United States locations

U.S. sites
10
U.S. states
9
U.S. cities
10
Facility City State ZIP Site status
City of Hope National Medical Center Duarte California 91010
Stanford University School of Medicine- Standford Cancer Institute Palo Alto California 94305
Georgia Cancer Center at Augusta University Augusta Georgia 30912
University of Kansas Cancer Center Fairway Kansas 66205
Johns Hopkins University Baltimore Maryland 21287
Massachusetts General Hospital Boston Massachusetts 02114
University of Nebraska Medical Center Omaha Nebraska 68105
Hackensack University Medical Center Hackensack New Jersey 07601
Duke University Durham North Carolina 27710
Vanderbilt Ingram Cancer Center Nashville Tennessee 37232

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04075747, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 15, 2023 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04075747 live on ClinicalTrials.gov.

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