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Last Updated: November 12, 2019

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CLINICAL TRIALS PROFILE FOR MOMELOTINIB

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Clinical Trials for Momelotinib

Trial ID Title Status Sponsor Phase Summary
NCT01236638 Extension Study Evaluating the Long Term Safety and Efficacy Study of CYT387 in Primary Myelofibrosis (PMF) or Post-polycythemia Vera (PV) or Post-essential Thrombocythemia (ET) Completed Gilead Sciences Phase 2 This extension protocol to the core study CCL09101 allows patients who have tolerated the drug and derived a clinical benefit, to continue to receive treatment beyond the 9 cycles of the core protocol. Long term safety and efficacy of CYT387 will be evaluated.
NCT01423058 Safety Study Evaluating Twice-Daily Administration of Momelotinib in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis Completed Gilead Sciences Phase 1/Phase 2 The myeloproliferative neoplasms (MPN), most notably polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF) are a diverse but inter-related suite of clonal disorders of pluripotent hematopoietic stem cells (Tefferi et al., 2008). The MPN share a range of biological, pathological, and clinical features including the relative overproduction of one or more cells of myeloid origin, growth factor independent colony formation in vitro, marrow hypercellularity, extramedullary hematopoiesis, spleno- and hepatomegaly, and thrombotic and/or hemorrhagic diatheses (Tefferi et al., 2005). This is a multi-centre, open-label, non-randomized, dose-escalation study, to be conducted in two phases: a dose-escalation phase (Part 1), to determine the safety and tolerability of momelotinib (CYT387), and to identify a therapeutic dose for the expanded cohort; and a dose-confirmation phase (Part 2), which will be a cohort expansion at or below the MTD of momelotinib. In the Part I dose-escalation phase of the study, subjects will be assigned to dose levels in successive cohorts starting with a dose in the first cohort of 200 mg BID (twice daily with doses taken approximately 12 hours apart). Doses will be escalated by 50 mg BID per cohort until dose-limiting toxicities are observed. The dose level at which ≥2 of 6 subjects develop a first cycle dose-limiting toxicity (DLT) is defined as the DLT level. The maximum tolerated dose (MTD) is defined as the dose level below the DLT level. New dose levels may begin accrual only if all subjects at the current dose level have been observed for a minimum of 28 days from the first day of treatment. The dose level chosen for study in the dose confirmation phase of the study will be the MTD or a lower dose shown to have significant clinical activity (efficacy) as determined by the safety review committee. Subjects will be evaluated weekly for the first cycle, every 2 weeks during cycle 2, then monthly for 4 cycles for a total of 6 cycles. In the dose-confirmation phase of the study, approximately fifty (50) subjects will be treated at the MTD or at a lower dose shown to have significant clinical activity (efficacy) as chosen by the Safety Review Committee. In the dose confirmation phase of the study subjects will be evaluated every 2 weeks during the first treatment cycle, and then monthly for 5 cycles for a total of 6 cycles.
NCT01969838 Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis Active, not recruiting Gilead Sciences Phase 3 This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib 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 168 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.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Momelotinib

Condition Name

Condition Name for
Intervention Trials
Primary Myelofibrosis 5
Post-Essential Thrombocythemia Myelofibrosis 4
Post-Polycythemia Vera Myelofibrosis 3
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Condition MeSH

Condition MeSH for
Intervention Trials
Thrombocytosis 8
Thrombocythemia, Essential 8
Primary Myelofibrosis 8
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Clinical Trial Locations for Momelotinib

Trials by Country

Trials by Country for
Location Trials
United States 80
Canada 18
Australia 9
Germany 8
France 8
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Trials by US State

Trials by US State for
Location Trials
California 11
Texas 6
Florida 6
Arizona 6
Massachusetts 6
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Clinical Trial Progress for Momelotinib

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 3
Phase 2 6
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Active, not recruiting 6
Recruiting 2
Completed 2
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Clinical Trial Sponsors for Momelotinib

Sponsor Name

Sponsor Name for
Sponsor Trials
Gilead Sciences 12
Fred Hutchinson Cancer Research Center 1
National Heart, Lung, and Blood Institute (NHLBI) 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 12
NIH 2
Other 1
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