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Managed Access Program for Momelotinib in Myelofibrosis

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Available
CT.gov ID
NCT05582083
Collaborator
(none)

Study Details

Study Description

Brief Summary

Compassionate use access to Momelotinib/GSK3070785 for eligible participant with diagnosis of intermediate or high-risk myelofibrosis (MF), including primary myelofibrosis (PMF) or secondary myelofibrosis (post- polycythemia vera/ essential thrombocytopenia (PV/ET)), with anemia.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
Managed Access Program for Momelotinib in Patients With a Diagnosis of Intermediate or High-risk Myelofibrosis (MF), Including Primary Myelofibrosis (PMF) or Secondary Myelofibrosis (Post- Polycythemia Vera/ Essential Thrombocytopenia (PV/ET)), With Anaemia

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Written informed consent can be obtained from the patient or legally authorised representative as per local regulations

    • Diagnosis of intermediate or high-risk myelofibrosis (MF), including primary myelofibrosis (PMF) or secondary myelofibrosis (post- polycythemia vera/ essential thrombocytopenia (PV/ET)), with anemia

    • 18 years or older (at the time consent is obtained)

    • The patient is willing to abide by the contraception requirements.

    • No known hypersensitivity to momelotinib, its metabolites, or any of the formulation excipients

    Exclusion Criteria:
    • Pregnant or breastfeeding female

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT05582083
    Other Study ID Numbers:
    • 219595
    First Posted:
    Oct 17, 2022
    Last Update Posted:
    Oct 17, 2022
    Last Verified:
    Oct 1, 2022
    Keywords provided by GlaxoSmithKline
    Momelotinib
    GSK3070785
    Additional relevant MeSH terms:
    Primary Myelofibrosis
    N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide

    Study Results

    No Results Posted as of Oct 17, 2022