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 — Simplify 2

Primary Myelofibrosis (PMF) Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Polycythemia
Polycythemia Vera
Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
Post-polycythemia Vera (Post-PV)
Primary Myelofibrosis
Primary Myelofibrosis (PMF)
Thrombocythemia, Essential
Thrombocytosis

Clinical Trial Details

NCT number	NCT02101268
Study type	Interventional
Source	Sierra Oncology, Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	June 19, 2014
Completion date	April 25, 2019

View Details

See also
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Completed	`NCT03136185` - Bomedemstat (IMG-7289/MK-3543) in Participants With Myelofibrosis (IMG-7289-CTP-102/MK-3543-002)	Phase 1/Phase 2
Completed	`NCT04217993` - Jaktinib for the Treatment of Ruxolitinib Intolerance of Myelofibrosis	Phase 2
Completed	`NCT02515630` - Momelotinib in Transfusion-Dependent Adults With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)	Phase 2
Recruiting	`NCT03662126` - KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment	Phase 2/Phase 3
Terminated	`NCT03935555` - Assess the Safety, Tolerability Oral PU-H71 in Subjects Taking Ruxolitinib	Phase 1
Recruiting	`NCT04878003` - Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis	Phase 2
Available	`NCT04745637` - Managed Access Programs for INC424, Ruxolitinib