NCT04679870

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral GB2064 in Participants With Myelofibrosis

An Open-label, Phase IIa Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral GB2064 (a LOXL2 Inhibitor) in Participants With Myelofibrosis (MF)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Galecto Biotech AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open label, phase IIa trial in subjects with Myelofibrosis

Detailed description

This study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GB2064 a LOXL-2 inhibitor over 9 months. Subjects will receive doses of GB2064, given twice per day to participants with primary or secondary Myelofibrosis

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
DRUG	GB2064	GB2064 (formerly PAT-1251) is a high-affinity, selective, mechanism-based, small molecule inhibitor of LOXL2, administered twice a day

Timeline

• Start date: 2021-06-09
• Primary completion: 2023-12-31
• Completion: 2026-06-30
• First posted: 2020-12-22
• Last updated: 2024-04-03

Locations

11 sites across 4 countries: United States, Australia, Germany, Italy

Regulatory

• FDA-regulated drug study