Trial intelligence / Profile preview

PLX3397 in Relapsed/Refractory FLT3-ITD+ AML

NCT01349049Phase 2

Key facts

Status: Completed
Start: Nov 2011
Primary completion: Jan 2015
Countries: 1
Sponsor: Daiichi Sankyo Co., Ltd.
Modality: Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands

Drugs: pexidartinib
Conditions: acute myeloid leukemia (AML)

Overview

Phase 2, open-label trial of pexidartinib in acute myeloid leukemia (AML) (8 arms), sponsored by Daiichi Sankyo Co., Ltd. Primary endpoints: Summary of Best Modified Criteria Response Results at 1 year, Bridged-to-Transplant (BTT) Participants at 1 year and 2 more. Started Nov 2011; status: completed.

Design

8 arms

Study design: Non-randomizedOpen-label

Level 0 (800 mg)
PLX3397 800 mg/day
Level 1 (1000 mg)
PLX3397 1000 mg/day
Level 2 (1200 mg)
PLX3397 1200 mg/day
Level 3 (1400 mg)
PLX3397 1400 mg/day
Level 4 (2000 mg)
PLX3397 2000 mg/day
Level 5 (3000 mg) / RP2D
PLX3397 3000 mg/day (RP2D)

2 more in the full profile.

Who it enrols

Adults with relapsed or refractory FLT3-ITD positive AML, adequate organ function, and no active CNS leukemia or recent HSCT.

Endpoints

Primary

Summary of Best Modified Criteria Response Results1 year
Bridged-to-Transplant (BTT) Participants1 year
Composite Remission Rates1 year
Summary of Time-to-Event Endpoints1 year

Secondary

Number of Participants With On-treatment Best Modified Criteria Response Results of Partial Remission (PR)1 year
Number of Participants With On-treatment Best Classic Criteria Response Results1 year
Number of Participants Reporting an Incidence of Adverse Events1 year
Number of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events1 year
Number of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade >=31 year
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events1 year

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