Extended Access of Momelotinib in Adults With Myelofibrosis

Phase 2

Active, not recruiting

• Conditions: Neoplasms; Post-polycythemia Vera Myelofibrosis (Post-PV MF); Primary Myelofibrosis (PMF); Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
• Interventions: Drug: MMB

• Registration Number: NCT03441113
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The primary objective of this study is to provide extended access and assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in studies GS-US-352-0101 (NCT01969838), GS-US-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), SRA-MMB-301 who are currently receiving treatment with MMB (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease. The secondary objective is to assess overall survival (OS) and leukemia free survival (LFS) in all subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-22
• Study Start: 2018-05-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

• Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
• Able to comprehend and willing to sign the informed consent form

Key

Exclusion Criteria

• Known hypersensitivity to MMB, its metabolites, or formulation excipients

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3: Study GS-US-352-1154	MMB	Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-1154 until MMB receives regulatory approval and is commercially available, or development of the product ceases..
Cohort 2: Study GS-US-352-1214	MMB	Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-1214 until MMB receives regulatory approval and is commercially available, or development of the product ceases.
Cohort 4: Study SRA-MMB-301	MMB	Participants will continue to receive the same dosage regimen as in the previous MMB study SRA-MMB-301 until MMB receives regulatory approval and is commercially available, or development of the product ceases.
Cohort 1: Study GS-US-352-0101	MMB	Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-0101 until MMB receives regulatory approval and is commercially available, or development of the product ceases.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Had Access to, and Received the Intervention	Participants will be assessed every 12 weeks until discontinuation. Participation in this extended access study has been an average of approximately 8 months.

Trial Locations

Locations (114)

IC Irvine Health; 🇺🇸 Orange, California, United States

GSK Investigational Site; 🇬🇧 Oxford., United Kingdom

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Winship Cancer Institute, Emory University; 🇺🇸 Atlanta, Georgia, United States

Northwest Oncology & Hematology - Rolling Meadows; 🇺🇸 Rolling Meadows, Illinois, United States

Saint Agnes Hospital; 🇺🇸 Baltimore, Maryland, United States

Dana-Farber Cancer Institute (DFCI); 🇺🇸 Boston, Massachusetts, United States

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