Last updated: 05/15/2024 17:50:07
Extended Access of Momelotinib in Adults with Myelofibrosis
GSK study ID
219627
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: Extended Access of Momelotinib for Subjects with Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of Participants Who Had Access to, and Received the Intervention
Timeframe: Participants will be assessed every 12 weeks until discontinuation. Participation in this extended access study has been an average of approximately 8 months.
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
237
Primary completion date:
2026-31-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Post-polycythemia Vera Myelofibrosis (Post-PV MF)
Product
Not applicable
Collaborators
Not applicable
Study date(s)
May 2018 to December 2026
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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
- Known hypersensitivity to MMB, its metabolites, or formulation excipients
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Inclusion and exclusion criteria
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
Exclusion criteria:
- Known hypersensitivity to MMB, its metabolites, or formulation excipients NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial location(s)
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21229-5299
Status
Recruiting
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
Location
GSK Investigational Site
Airdrie, Lanarkshire, United Kingdom, ML6 0JS
Status
Recruiting
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Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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