Extended Access of Momelotinib in Adults With Myelofibrosis

GlaxoSmithKline (GSK)

Status and phase: Active, not recruiting; Phase 2

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

Treatments: Drug: MMB

Study type: Interventional

Funder types: Industry

Identifiers

NCT03441113

219627 (Other Identifier)

2017-004350-42 (EudraCT Number)

SRA-MMB-4365

Details and patient eligibility

About

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.

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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237 participants in 4 patient groups

Cohort 1: Study GS-US-352-0101

Other group

Description:

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.

Treatment:

Drug: MMB

Cohort 2: Study GS-US-352-1214

Other group

Description:

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.

Treatment:

Drug: MMB

Cohort 3: Study GS-US-352-1154

Other group

Description:

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..

Treatment:

Drug: MMB

Cohort 4: Study SRA-MMB-301

Other group

Description:

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.

Treatment:

Drug: MMB