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Be Part of Research - Trial Details - Extended Access of Momelotinib in Adults With Myelofibrosis

Extended Access of Momelotinib in Adults With Myelofibrosis

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

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


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

May 2018 Dec 2026

Publications

"Gerds AT, Verstovsek S, Vannucchi AM, Al-Ali HK, Lavie D, Kuykendall AT, Grosicki S, Iurlo A, Goh YT, Lazaroiu MC, Egyed M, Fox ML, McLornan D, Perkins A, Yoon SS, Gupta V, Kiladjian JJ, Granacher N, Lee SE, Ocroteala L, Passamonti F, Harrison CN, Oh S, Klencke BJ, Yu J, Donahue R, Kawashima J, Mesa R. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis previously treated with a JAK inhibitor (MOMENTUM): an updated analysis of an international, double-blind, randomised phase 3 study. Lancet Haematol. 2023 Sep;10(9):e735-e746. doi: 10.1016/S2352-3026(23)00174-6. Epub 2023 Jul 27."; "37517413"; "Verstovsek S, Mesa R, Gupta V, Lavie D, Dubruille V, Cambier N, Platzbecker U, Hus M, Xicoy B, Oh ST, Kiladjian JJ, Vannucchi AM, Gerds A, Egyed M, Mayer J, Sacha T, Kawashima J, Morris M, Huang M, Harrison C. Momelotinib long-term safety and survival in myelofibrosis: integrated analysis of phase 3 randomized controlled trials. Blood Adv. 2023 Jul 25;7(14):3582-3591. doi: 10.1182/bloodadvances.2022009311."; "37042865"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Tablet(s) administered orally once daily

Intervention Arm Group : Cohort 1: Study GS-US-352-0101;Cohort 2: Study GS-US-352-1214;Cohort 3: Study GS-US-352-1154;Cohort 4: Study SRA-MMB-301;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University Hospital of Wales
    Cardiff
    CF14 4XW
  • GSK Investigational Site
    London
    W12 0HS
  • GSK Investigational Site
    Bristol
    BS2 8ED
  • GSK Investigational Site
    Cardiff
    CF14 4XW
  • GSK Investigational Site
    Airdrie
    Lanarkshire
    ML6 0JS
  • GSK Investigational Site
    Oxford
    OX3 7LE
  • University Hospitals Bristol and Weston NHS Foundation Trust
    Bristol
    England
    BS2 8ED
  • NHS Lanarkshire
    Airdrie
    Scotland
    ML6 0JS
  • Imperial College Healthcare NHS Trust
    London
    W12 ONN
  • Oxford University Hospitals NHS Trust
    Oxford
    OX3 7LJ


The study is sponsored by GlaxoSmithKline




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Read full details for Trial ID: NCT03441113
Last updated 15 May 2024

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