Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia
NCT ID: NCT01998828
Last Updated: 2020-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
39 participants
INTERVENTIONAL
2014-02-19
2015-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Momelotinib 100 mg PV
Participants with polycythemia vera will receive 100 mg of momelotinib.
Momelotinib
Momelotinib tablet administered orally once daily
Momelotinib 200 mg PV
Participants with polycythemia vera will receive 200 mg of momelotinib.
Momelotinib
Momelotinib tablet administered orally once daily
Momelotinib 100 mg ET
Participants with essential thrombocythemia will receive 100 mg of momelotinib.
Momelotinib
Momelotinib tablet administered orally once daily
Momelotinib 200 mg ET
Participants with essential thrombocythemia will receive 200 mg of momelotinib.
Momelotinib
Momelotinib tablet administered orally once daily
Interventions
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Momelotinib
Momelotinib tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Sierra Oncology LLC - a GSK company
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Lee, MD, PhD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
Countries
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References
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Verstovsek S, Courby S, Griesshammer M, Mesa RA, Brachmann CB, Kawashima J, Maltzman JD, Shao L, Xin Y, Huang D, Bajel A. A phase 2 study of momelotinib, a potent JAK1 and JAK2 inhibitor, in patients with polycythemia vera or essential thrombocythemia. Leuk Res. 2017 Sep;60:11-17. doi: 10.1016/j.leukres.2017.05.002. Epub 2017 May 30.
Other Identifiers
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2013-004105-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-354-0101
Identifier Type: -
Identifier Source: org_study_id
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