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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
237
Tablet(s) administered orally once daily
IC Irvine Health
Orange, California, United States
GSK Investigational Site
Stanford, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
GSK Investigational Site
Aurora, Colorado, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Number of Participants Who Had Access to, and Received the Intervention
Time frame: Participants will be assessed every 12 weeks until discontinuation. Participation in this extended access study has been an average of approximately 8 months.
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GSK Investigational Site
Jacksonville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
...and 214 more locations