Trials / Active Not Recruiting
Active Not RecruitingNCT03441113
Extended Access of Momelotinib in Adults With Myelofibrosis
Extended Access of Momelotinib for Subjects With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 237 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Neoplasms
- Post-polycythemia Vera Myelofibrosis (Post-PV MF)
- Primary Myelofibrosis (PMF)
- Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MMB | Tablet(s) administered orally once daily |
Timeline
- Start date
- 2018-05-03
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2018-02-22
- Last updated
- 2024-05-16
Locations
224 sites across 20 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Singapore, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03441113. Inclusion in this directory is not an endorsement.