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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 is a Phase 3 study that has completed, run by Sierra Oncology LLC - a GSK company. The registered enrollment target is 156 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02101268
The ClinicalTrials.gov registry entry for NCT02101268 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sierra Oncology LLC - a GSK company, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Momelotinib is the first listed.
NCT02101268 reports 0 study locations.
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.
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