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Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia
Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia

NCT02124746

CompletedPhase 2

Sponsor: Sierra Oncology LLC - a GSK company

Conditions: Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, Polycythemia Vera, Essential Thrombocythemia

Interventions: Momelotinib

Countries: United States, Australia, Canada, France, Germany

This open-label study is to determine the long-term safety and tolerability of momelotinib in previously enrolled study participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), post-essential thrombocythemia myelofibrosis (post-ET MF), polycythemia vera (PV), or essential thrombocythemia (ET), who have tolerated and achieved stable disease or better with momelotinib treatment while enrolled in a previous clinical trial.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* Currently enrolled in study CCL09101E, or YM387-II-02, or successfully completed 24 weeks of study GS-US-352-1672
* Able to comprehend and willing to sign informed consent form

Key Exclusion Criteria:

* Known hypersensitivity to momelotinib, its metabolites, or formulation excipients

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations (22)
  • Scottsdale, Arizona, United States
  • Orange, California, United States
  • Stanford, California, United States
  • Whittier, California, United States
  • Jacksonville, Florida, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • Cleveland, Ohio, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Frankston, Victoria, Australia
  • Parkville, Victoria, Australia
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • La Tronche, France
  • Paris, France
  • Minden, Germany