Clinical Trial: NCT01969838
Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Sierra Oncology LLC - a GSK company |
| Information Provided By: | Sierra Oncology LLC - a GSK company |
| Last Update Posted: | 2023-05-12 |
Study Overview
Brief Summary
This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor).
Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.
Official Title
Conditions
Intervention / Treatment
- Drug: Momelotinib
- Drug: Ruxolitinib
- Drug: Placebo to match momelotinib
- Drug: Placebo to match ruxolitinib
Other Study ID Numbers
- GS-US-352-0101
- 2013-002707-33
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Sierra Oncology LLC - a GSK company |
| Information Provided By: | Sierra Oncology LLC - a GSK company |
| Last Update Posted: | 2023-05-12 |
Study Overview
Brief Summary
This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor).
Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.
Official Title
Conditions
Intervention / Treatment
- Drug: Momelotinib
- Drug: Ruxolitinib
- Drug: Placebo to match momelotinib
- Drug: Placebo to match ruxolitinib
Other Study ID Numbers
- GS-US-352-0101
- 2013-002707-33