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Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia

NCT01998828

TerminatedPhase 2

Sponsor: Sierra Oncology LLC - a GSK company

Conditions: Polycythemia Vera, Essential Thrombocythemia

Interventions: Momelotinib

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

This open-label study is to determine the safety and efficacy of momelotinib in participants with either polycythemia vera (PV) or essential thrombocythemia (ET) who have not yet received treatment with a Janus kinase (JAK) inhibitor.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Diagnosis of either PV or ET as defined by the 2008 World Health Organization (WHO) Diagnostic Criteria
* Requires treatment for PV or ET, in the opinion of the study investigator
* Intolerant of, resistant to, or refuses current or available treatment for PV or ET
* Direct bilirubin ≤ 2.0 x upper limit of the normal range (ULN)
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
* Calculated creatinine clearance (CrCl) of ≥ 45 mL/min
* Life expectancy \> 24 weeks
* Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Females who are nursing must agree to discontinue nursing before the first dose of study drug
* Able to comprehend and willing to sign informed consent form

Exclusion Criteria:

* Prior splenectomy
* Uncontrolled intercurrent illness, per protocol
* Known positive status for human immunodeficiency virus (HIV)
* Chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier
* Myeloproliferative neoplasm-directed therapy, other than aspirin, hydroxyurea, anagrelide, and/or phlebotomy, within 21 days prior to the first dose of study drug
* Anagrelide within 7 days prior to the first dose of study drug
* Presence of peripheral neuropathy ≥ Grade 2
* Unwilling or unable to take oral medication
* Prior use of a JAK1 or JAK2 inhibitor
* Use of strong CYP3A4 inducers within 1 week prior to the first dose of study drug
* QTc interval \> 450 msec, unless attributed to bundle branch block

Locations (15)

Scottsdale, Arizona, United States
Whittier, California, United States
Tupelo, Mississippi, United States
St Louis, Missouri, United States
Houston, Texas, United States
Frankston, Victoria, Australia
Parkville, Victoria, Australia
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
La Tronche, France
Nantes, France
Paris, France
Dresden, Germany
Minden, Germany