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

Sierra Oncology

Status and phase: Completed; Phase 2

Conditions: Polycythemia Vera; Primary Myelofibrosis; Post-Essential Thrombocythemia Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Essential Thrombocythemia

Treatments: Drug: Momelotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02124746

2013-004476-36 (EudraCT Number)

GS-US-352-1154

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 4 patient groups

Cohort 1

Experimental group

Description:

Participants previously enrolled in Study CCL09191E will receive momelotinib for approximately 4 years.

Treatment:

Drug: Momelotinib

Cohort 2

Experimental group

Description:

Participants previously enrolled in Study YM387-II-02 will receive momelotinib for approximately 4 years.

Treatment:

Drug: Momelotinib

Cohort 3

Experimental group

Description:

Participants previously enrolled in Study GS-US-354-0101 will receive momelotinib for up to 4 years. Cohort 3 was closed and all enrolled participants were discontinued from this study because parent Study GS-US-354-0101 was terminated.

Treatment:

Drug: Momelotinib

Cohort 4

Experimental group

Description:

Participants previously enrolled in Study GS-US-352-1672 will receive momelotinib for approximately 4 years.

Treatment:

Drug: Momelotinib