Phase 2 Completed N=74 Treatment

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

Myelofibrosis · Post-Polycythemia Vera Myelofibrosis · Post-Essential Thrombocythemia Myelofibrosis · Polycythemia Vera

Source: ClinicalTrials.gov NCT02124746 ↗

Enrolled (actual)

Serious AEs

66.2%

Results posted

Feb 2021

Primary outcomePrimary: Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities — 73; 62; 36; 16 Participants

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.

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.