Extended Access of Momelotinib in Adults With Myelofibrosis

Study Overview
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Brief Summary
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The primary objective of this study is to provide extended access and assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in studies GS-US-352-0101 (NCT01969838), GS-US-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), SRA-MMB-301 who are currently receiving treatment with MMB (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease. The secondary objective is to assess overall survival (OS) and leukemia free survival (LFS) in all subjects.

Official Title
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Extended Access of Momelotinib for Subjects With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

Conditions
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Neoplasms, Post-polycythemia Vera Myelofibrosis (Post-PV MF), Primary Myelofibrosis (PMF), Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)

Intervention / Treatment
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* Drug: MMB


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301 Able to comprehend and willing to sign the informed consent form Key Exclusion Criteria: Known hypersensitivity to MMB, its metabolites, or formulation excipients NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort 1: Study GS-US-352-0101<br>Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-0101 until MMB receives regulatory approval and is commercially available, or development of the product ceases. | Drug: MMB<br>* Tablet(s) administered orally once daily<br>* Other names: CYT387;|
| Other: Cohort 2: Study GS-US-352-1214<br>Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-1214 until MMB receives regulatory approval and is commercially available, or development of the product ceases. | Drug: MMB<br>* Tablet(s) administered orally once daily<br>* Other names: CYT387;|
| Other: Cohort 3: Study GS-US-352-1154<br>Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-1154 until MMB receives regulatory approval and is commercially available, or development of the product ceases.. | Drug: MMB<br>* Tablet(s) administered orally once daily<br>* Other names: CYT387;|
| Other: Cohort 4: Study SRA-MMB-301<br>Participants will continue to receive the same dosage regimen as in the previous MMB study SRA-MMB-301 until MMB receives regulatory approval and is commercially available, or development of the product ceases. | Drug: MMB<br>* Tablet(s) administered orally once daily<br>* Other names: CYT387;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had Access to, and Received the Intervention |  | Participants will be assessed every 12 weeks until discontinuation. Participation in this extended access study has been an average of approximately 8 months. |