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臨床試驗計畫

計劃書編號SRA-MMB-4365
尚未開始召募

2018-06-01 - 2023-12-31

Phase II

終止收納2

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

  • 試驗申請者

    保瑞爾生技股份有限公司

  • 試驗委託 / 贊助單位名稱

    Sierra Oncology Inc.

  • 臨床試驗規模

    多國多中心

  • 更新日期

    2026/04/01

試驗主持人及試驗醫院

試驗主持人 王銘崇 未分科

協同主持人

實際收案人數

0 停止召募

試驗主持人 劉大智 未分科

協同主持人

實際收案人數

0 停止召募

適應症

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

試驗目的

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 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 -Cohort 4:Study SRA-MMB-301, subjects with PMF or post-PV/ET MF

藥品名稱

Momelotinib Film-coated Tablets

主成份

Momelotinib

劑型

Film-coated

劑量

50mg, 100mg, 150mg, 200mg

評估指標

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

主要納入條件

Inclusion 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
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

試驗計畫預計收納受試者人數

  • 台灣人數

  • 全球人數