Managed Access Program for Momelotinib in Myelofibrosis

NCT05582083 | Unknown

• 1 other identifier: 219595
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myelofibrosis; Primary Myelofibrosis

Keywords

Momelotinib; GSK3070785

Interventions

Momelotinib DRUG

Momelitinib available as tablets.

Also known as: GSK3070785

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Pregnant or breastfeeding female

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 17, 2022
• Last Updated: November 8, 2023

Record last verified: 2023-11