Phase 2
N=74
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
Primary Myelofibrosis · Post-Polycythemia Vera Myelofibrosis · Post-Essential Thrombocythemia Myelofibrosis · Polycythemia Vera · Essential Thrombocythemia
Bottom Line
View on ClinicalTrials.gov: NCT02124746 ↗Enrolled (actual)
74
Serious AEs
66.2%
Results posted
Feb 2021
Primary outcome: Primary: Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities — 73; 62; 36; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Momelotinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sierra Oncology LLC - a GSK company
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities |
73; 62; 36; 16 | — |
| SECONDARY Splenic Response Rate |
20; 19; 6; 45 | — |
| SECONDARY Duration of Splenic Response |
1704.5; 736.0; 447.5; 990.0 | — |
| SECONDARY Transfusion Independence Response Rate |
7; 5; 16; 28 | — |
| SECONDARY Duration of Transfusion Independence Response |
357.0; 114.0; 281.5; 193.5 | — |
| SECONDARY Anemia Response Rate |
13; 6; 16; 35 | — |
| SECONDARY Duration of Anemia Response |
995.0; 120.0; 281.5; 358.0 | — |
| SECONDARY Rate of RBC Transfusion |
0.08; 0.00; 0.06 | — |
| SECONDARY Overall Survival |
NA; NA; NA; NA | — |
| SECONDARY Progression-Free Survival |
NA; NA; NA; NA | — |
| SECONDARY Leukemia-Free Survival |
NA; NA; NA; NA | — |
Summary
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 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.
Data sourced from ClinicalTrials.gov (NCT02124746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.