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Clinical Trials List

Protocol NumberSRA-MMB-4365

2018-06-01 - 2023-12-31

Phase II

Recruiting3

Terminated1

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

Trial Applicant

Pharmaceutical Research Associates Taiwan Inc.
Sponsor

Sierra Oncology Inc.
Trial scale

Multi-Regional Multi-Center
Update

2023/03/10

Investigators and Locations

Principal Investigator 馬銘君未分科

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

王銘崇未分科

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yi-Chang Liu 未分科

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

Hui-Hua Hsiao 未分科
Ta-Chih Liu Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung Chang 未分科

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

Lee-Yung Shin 未分科

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator HSIN-AN HOU 未分科

National Taiwan University Hospital

Co-Principal Investigator

- - 未分科

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post- Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

Objectives

To provide extended access to momelotinib in 4 cohorts of subjects who are currently receiving treatment with MMB and have not experienced progression of disease: Cohort 1: Study GS-US-352-0101, subjects with primary myelofibrosis (PMF) or post polycythemia vera/essential thrombocythemia myelofibrosis (post-PV/ET MF) Cohort 2: Study GS-US-352-1214, subjects with PMF or post-PV/ET MF Cohort 3: Study GS-US-352-1154, subjects with PMF or post-PV/ET MF

Test Drug

Momelotinib Film-coated Tablets

Active Ingredient

Momelotinib

Dosage Form

Film-coated

Dosage

100mg, 150mg, 200mg

Endpoints

Safety: Safety will be evaluated by the incidence and severity of AEs.

Inclution Criteria

1) Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, or GS-US-352-1154, or SRA-MMB-301
2) Did not discontinue treatment with MMB for any reason while enrolled in Studies GS-US-352-0101, GS-US-352-1214, or GS-US-352-1154, or SRA-MMB-301
3) Negative serum or urine pregnancy test is required for female subjects of childbearing potential as described in Appendix 3
4) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 3
5) Any Grade 3 or 4 (Common Terminology Criteria for Adverse Events [CTCAE] Version 4.03) non-hematologic toxicity in the prior study that the investigator considers related to previous MMB use must have resolved, reverted to Grade 1, or reverted to baseline within the 30 days from the last MMB administration to Day 1 of this study
6) Any adverse event (AE) requiring MMB interruption during the prior study must have resolved, reverted to Grade 1, or reverted to baseline within the 30 days from last MMB administration to Day 1 of this study
7) Ability and agreement to attend protocol-specified visits at the study site
8) Able to comprehend and willing to sign the informed consent form

Exclusion Criteria

Exclusion Criteria
1) Known hypersensitivity to MMB, its metabolites, or formulation excipients
2) Incomplete recovery from major surgery prior to Day 1 of this study
3) Pregnant or lactating females
4) Presence of >/= Grade 3 (CTCAE Version 4.03) peripheral neuropathy
5) Known positive status for human immunodeficiency virus (HIV)
6) Known chronic active or acute viral hepatitis A, B, or C infection

The Estimated Number of Participants

Taiwan

5 participants
Global

200 participants