The trial is taking place at:
H

Hospital Universitario Puerta de Hierro Majadahonda | Departamento de Oncologia Medica

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Extended Access of Momelotinib in Adults With Myelofibrosis

GlaxoSmithKline (GSK) logo

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)

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

Trial contacts and locations

224

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Data sourced from clinicaltrials.gov

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