Managed Access Program for Momelotinib in Myelofibrosis

NCT ID: NCT05582083

Last Updated: 2023-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Myelofibrosis Primary Myelofibrosis

Interventions

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Momelotinib

Momelitinib available as tablets.

Intervention Type DRUG

Other Intervention Names

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GSK3070785

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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219595

Identifier Type: -

Identifier Source: org_study_id

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