Neoplasms, Post-essential Thrombocythemia Myelofibrosis (Post-ET MF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), Primary Myelofibrosis, Primary Myelofibrosis (PMF)
Conditions
Brief 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.
Interventions
DRUGMMB
Tablet(s) administered orally once daily
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Outcome results
None listed