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NCT02101268 · ClinicalTrials.gov registry record · Phase 3
Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF
A Phase 3 study, sponsored by Sierra Oncology LLC - a GSK company.
- Completed
- Registry status
- Phase 3
- Development phase
- 156
- Enrollment target
NCT02101268: Completed Phase 3 study, sponsored by Sierra Oncology LLC - a GSK company.
NCT02101268 is a Phase 3 study that has completed, run by Sierra Oncology LLC - a GSK company. The registered enrollment target is 156 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02101268, a Phase 3 study, has completed, sponsored by Sierra Oncology LLC - a GSK company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 156 participants
- Enrollment target
Study Summary
This study is to determine the efficacy of momelotinib (MMB) versus best available therapy (BAT) in anemic or thrombocytopenic adults with primary myelofibrosis (PMF), or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) who were treated with ruxolitinib as measured by splenic response rate at Week 24 (SRR24). Participants will be randomized to receive either MMB or BAT for 24 weeks during the randomized treatment phase, after which they will be eligible to receive MMB in an extended treatment phase for up to an additional 204 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 subjects planning to continue treatment with MMB following the end of the study, the End of Treatment, 30-day, 12-Week, and survival follow-up visits are not required.
Primary Outcome
Splenic response rate at Week 24 is defined as the percentage of participants who achieved a spleen volume reduction of ≥ 35% from baseline at the Week 24 assessment as measured by MRI or CT.
Interventions
- DRUG Momelotinib
- DRUG Best Available Therapy (BAT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2014-06-19 |
| Est. Completion | 2019-04-25 |
| Phase | Phase 3 |
What the finished NCT02101268 record still lists
NCT02101268 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Momelotinib is the first listed.
NCT02101268 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02101268 about?
NCT02101268 is a clinical study titled "Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF". This study is to determine the efficacy of momelotinib (MMB) versus best available therapy (BAT) in anemic or thrombocytopenic adults with primary myelofibrosis (PMF), or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) who were treated with ruxolitinib as measu...
What is the current status of trial NCT02101268?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 156 participants. The study started on 2014-06-19. Estimated completion is 2019-04-25.
What interventions are being tested in trial NCT02101268?
The interventions under investigation include: Momelotinib (DRUG), Best Available Therapy (BAT) (DRUG).
Who is sponsoring clinical trial NCT02101268?
This trial is sponsored by Sierra Oncology LLC - a GSK company, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02101268's enrollment target sits among peer trials
156 1506th of 2000 higher than 492 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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