Clinical trial · Interventional
Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia
A Phase 2, Open-label, Randomized Study to Evaluate the Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia
NCT01998828CI-TRIAL-00044737terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Essential Thrombocythemia | Essential Thrombocythemia | ONTOLOGY_EXACT | 0.98 |
| Polycythemia Vera | Polycythemia Vera | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Momelotinib | Drug | Momelotinib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Momelotinib 100 mg PV
- description
- Participants with polycythemia vera will receive 100 mg of momelotinib.
- interventionNames
- Drug: Momelotinib
- type
- EXPERIMENTAL
- label
- Momelotinib 200 mg PV
- description
- Participants with polycythemia vera will receive 200 mg of momelotinib.
- interventionNames
- Drug: Momelotinib
- type
- EXPERIMENTAL
- label
- Momelotinib 100 mg ET
- description
- Participants with essential thrombocythemia will receive 100 mg of momelotinib.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDVerstovsek 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. PMID 28622623