Extended Access of Momelotinib in Adults With Myelofibrosis

NCT03441113 · tracked via the Priya Life Science UK tracker

Sponsor

GlaxoSmithKline

Phase

Phase 2

Started

2018-05-03

Last updated

2026-06-18

Condition(s) studied

NeoplasmsPost-polycythemia Vera Myelofibrosis (Post-PV MF)Primary Myelofibrosis (PMF)Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)Primary Myelofibrosis

Investigational drug(s) / intervention(s)

MMB

MMB: Tablet(s) administered orally once daily

Study summary

The primary objective of this study is to provide extended access and assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in studies GS-US-352-0101 (NCT01969838), GS-US-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), SRA-MMB-301 who are currently receiving treatment with MMB (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease. The secondary objective is to assess overall survival (OS) and leukemia free survival (LFS) in all subjects.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Key Inclusion Criteria: * Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301 * Able to comprehend and willing to sign the informed consent form Key Exclusion Criteria: * Known hypersensitivity to MMB, its metabolites, or formulation excipients NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Primary outcome measure(s)

Number of Participants Who Had Access to, and Received the Intervention — Participants will be assessed every 12 weeks until discontinuation. Participation in this extended access study has been an average of approximately 8 months.

Trial sites (112)

Facility	City	Region
GSK Investigational Site	Scottsdale	Arizona
GSK Investigational Site	Orange	California
GSK Investigational Site	Stanford	California
GSK Investigational Site	Aurora	Colorado
GSK Investigational Site	Jacksonville	Florida
GSK Investigational Site	Tampa	Florida
GSK Investigational Site	Atlanta	Georgia
GSK Investigational Site	Baltimore	Maryland
GSK Investigational Site	Boston	Massachusetts
GSK Investigational Site	Rochester	Minnesota
GSK Investigational Site	St Louis	Missouri
GSK Investigational Site	Hackensack	New Jersey
GSK Investigational Site	The Bronx	New York
GSK Investigational Site	Cleveland	Ohio
GSK Investigational Site	South Brisbane	Queensland
GSK Investigational Site	Bedford Park	South Australia
GSK Investigational Site	Frankston	Victoria
GSK Investigational Site	Melbourne	Victoria
GSK Investigational Site	Melbourne	Victoria
GSK Investigational Site	Perth	Western Australia
GSK Investigational Site	Linz	Austria
GSK Investigational Site	Vienna	Austria
GSK Investigational Site	Antwerp	Belgium
GSK Investigational Site	Bruges	Belgium
GSK Investigational Site	Leuven	Belgium
GSK Investigational Site	Liège	Belgium
GSK Investigational Site	Pleven	Bulgaria
GSK Investigational Site	Rousse	Bulgaria
GSK Investigational Site	Sofia	Bulgaria
GSK Investigational Site	Sofia	Bulgaria
GSK Investigational Site	Toronto	Ontario
GSK Investigational Site	Montreal	Quebec
GSK Investigational Site	Montreal	Quebec
GSK Investigational Site	Aalborg	Denmark
GSK Investigational Site	Herlev	Denmark
GSK Investigational Site	Le Mans	France
GSK Investigational Site	Lille	France
GSK Investigational Site	Marseille	France
GSK Investigational Site	Paris	France
GSK Investigational Site	Pessac	France

+ 72 more sites — see the full list on the official registry below.

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Other trials for the same condition

Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors Active, not recruiting

A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis Active, not recruiting

A Phase 1 Study of LY5830966 in Participants With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i) Recruiting

A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017) Recruiting

An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03441113 on ClinicalTrials.gov ↗ ← All trials in the UK