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Clinical Trials in Spain / NCT03441113
Active, not recruiting Phase 2

Extended Access of Momelotinib in Adults With Myelofibrosis

NCT03441113 · tracked via the Priya Life Science Spain 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
No
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)

FacilityCityRegionStatus
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.

More GlaxoSmithKline trials in Spain

REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study Active, not recruiting
A Study to Evaluate the Safety, Tolerability, and Effects on Blood and Urine Markers of Single Ascending Dose of GSK4771261 in Healthy Participants and Participants With Autosomal Dominant Polycystic Kidney Disease Active, not recruiting
First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combination in Adult Participants With Advanced Solid Tumors Recruiting
A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy Recruiting
A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) Recruiting

Other trials for the same condition

Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2) Active, not recruiting
Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib Recruiting
First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combination in Adult Participants With Advanced Solid Tumors 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
A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors 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 Spain