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Trial intelligence / Profile preview
GB2064 in Myelofibrosis
NCT04679870Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Jun 2021
- Primary completion
- Dec 2023
- Countries
- 4
- Sponsor
- Galecto, Inc.
- Modality
- Small Molecules
- Drugs
- lenumlostat
- Conditions
- myelofibrosis (MF)
01
Overview
Phase 2, open-label, single-arm trial of lenumlostat in myelofibrosis (MF), sponsored by Galecto, Inc. Primary endpoint: Adverse Events at 9 months. Started Jun 2021; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
GB2064
GB2064 1000 mg BID
03
Who it enrols
Adults with intermediate-2 or high-risk primary or secondary myelofibrosis (or low risk with symptomatic splenomegaly) who are refractory, intolerant, or ineligible for JAK inhibitors. Patients must have adequate organ function and no recent JAK inhibitor use.
04
Endpoints
Primary
Adverse Events
Secondary
Bone Marrow Fibrosis Grade
Hematologic Parameters
Spleen Volume Reduction
Total Symptom Score
Pharmacokinetics
Pharmacodynamics
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