Back to resultsManaged Access Program for Momelotinib in Myelofibrosis
Primary Purpose
Myelofibrosis
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Momelotinib
Sponsored by
About this trial
This is an expanded access trial for Myelofibrosis focused on measuring Momelotinib, GSK3070785
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
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Primary Completion Date
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Study Completion Date
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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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