This study is in progress, not accepting new patients

Extended Access of Momelotinib in Adults With Myelofibrosis

a study on Neoplasms Polycythemia Vera Primary Myelofibrosis Myelofibrosis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Angela Fleischman (uci)

Description

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.

Official Title

Extended Access of Momelotinib for Subjects With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

Keywords

Neoplasms, Post-polycythemia Vera Myelofibrosis (Post-PV MF), Primary Myelofibrosis (PMF), Post-essential Thrombocythemia Myelofibrosis (Post-ET MF), Primary Myelofibrosis, N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide, MMB, Study GS-US-352-0101, Study GS-US-352-1214, Study GS-US-352-1154, Study SRA-MMB-301

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

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

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

Locations

  • GSK Investigational Site
    Stanford California 94305-5821 United States
  • GSK Investigational Site
    Orange California 97239 United States

Lead Scientist at University of California Health

  • Angela Fleischman (uci)
    Associate Professor, Medicine, School of Medicine. Authored (or co-authored) 68 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
GlaxoSmithKline
ID
NCT03441113
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 237 people participating
Last Updated