Extended Access of Momelotinib in Adults With Myelofibrosis
Sponsor: GlaxoSmithKline
ClinicalTrials ID:NCT03441113
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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 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
Key
Exclusion Criteria
- Known hypersensitivity to MMB, its metabolites, or formulation excipients
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| IC Irvine Health | 92868 | Orange | California |
| GSK Investigational Site | 94305-5821 | Stanford | California |
| Stanford Hospital and Clinics | 94305 | Stanford | California |
| GSK Investigational Site | 80045 | Aurora | Colorado |
| University of Colorado Cancer Center | 80045 | Aurora | Colorado |
| GSK Investigational Site | 32224 | Jacksonville | Florida |
| Mayo Clinic Florida | 32224 | Jacksonville | Florida |
| GSK Investigational Site | 33612 | Tampa | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| GSK Investigational Site | 30322 | Atlanta | Georgia |
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