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Managed Access Program for Momelotinib in Myelofibrosis

Primary Purpose

Myelofibrosis

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Momelotinib
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Myelofibrosis focused on measuring Momelotinib, GSK3070785

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 12, 2022
    Last Updated
    October 12, 2022
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05582083
    Brief Title
    Managed Access Program for Momelotinib in Myelofibrosis
    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
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myelofibrosis
    Keywords
    Momelotinib, GSK3070785

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Momelotinib
    Other Intervention Name(s)
    GSK3070785
    Intervention Description
    Momelitinib available as tablets.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    US GSK Clinical Trials Call Center
    Phone
    877-379-3718
    Email
    GSKClinicalSupportHD@gsk.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    EU GSK Clinical Trials Call Center
    Phone
    +44 (0) 20 89904466
    Email
    GSKClinicalSupportHD@gsk.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Managed Access Program for Momelotinib in Myelofibrosis

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