This study is in progress, not accepting new patients

Extended Access of Momelotinib in Adults With Myelofibrosis

a study on Myelofibrosis Primary Myelofibrosis Polycythemia Vera Neoplasms

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

This is an extended-access, long-term safety study for participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) who have not experienced progression of disease and who have tolerated momelotinib (MMB) treatment while participating in previous MMB clinical trials (GS-US-352-0101 [NCT01969838], GS-US-352-1214 [NCT02101268], GS-US-352-1154 [NCT02124746] and SRA-MMB-301 [NCT04173494]). Participants in all cohorts continuing MMB treatment will discontinue MMB from the previous study and initiate MMB in this study at the same dose they were receiving in the previous study. Following the final data cut-off date, the study may move into the post analysis continuation of treatment (PACT) phase in which participants will continue to receive MMB and will be monitored and receive follow-up care in accordance with standard local clinical practice.

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

Primary Myelofibrosis, Neoplasms, Momelotinib, Extended access, Post-polycythemia Vera Myelofibrosis (Post-PV MF), Primary Myelofibrosis (PMF), Post-essential Thrombocythemia Myelofibrosis (Post-ET MF), N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide, 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
  • Did not discontinue treatment with MMB for any reason while enrolled in Studies GS US 352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
  • A negative serum or urine pregnancy test is required for female participants of childbearing potential
  • Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
  • Any Grade 3 or 4 (common terminology criteria for adverse events [CTCAE] Version 4.03) non-hematologic toxicity in the prior study that the Investigator considers related to previous MMB use must have resolved, reverted to Grade 1, or reverted to Baseline within the 30 days from last MMB administration to Day 1 of this study
  • Any AE requiring MMB interruption during the prior study must have resolved, reverted to Grade 1, or reverted to Baseline within the 30 days from last MMB administration to Day 1 of this study
  • Ability and agreement to attend protocol-specified visits at the study site
  • 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
  • Incomplete recovery from major surgery prior to Day 1 of this study
  • Pregnant or lactating females
  • Presence of greater than or equal to (>=) Grade 3 (CTCAE Version 4.03) peripheral neuropathy
  • Known positive status for human immunodeficiency virus (HIV)
  • Known chronic active or acute viral hepatitis A, B, or C infection

Locations

  • GSK Investigational Site
    Stanford California 94305-5821 United States
  • GSK Investigational Site
    Portland Oregon 97239-3011 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