NCT02101268

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, Randomized Study To Evaluate the Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis Who Were Treated With Ruxolitinib

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Sierra Oncology LLC - a GSK company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Myelofibrosis (PMF)
• Post-polycythemia Vera (Post-PV)
• Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)

Interventions

Type	Name	Description
DRUG	Momelotinib	Momelotinib tablet administered orally once daily
DRUG	Best Available Therapy (BAT)	Regimens for BAT may include but are not limited to chemotherapy (eg hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgen, interferon, and may include no myelofibrosis treatment.

Timeline

• Start date: 2014-06-19
• Primary completion: 2016-07-28
• Completion: 2019-04-25
• First posted: 2014-04-02
• Last updated: 2023-05-23
• Results posted: 2023-05-23

Locations

48 sites across 8 countries: United States, Canada, France, Germany, Israel, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study