Primary Myelofibrosis (PMF), Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF) MedDRA version: 20.0 Level: PT Classification code 10028537 Term: Myelofibrosis System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For subjects continuing MMB treatment: 1) Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, or GS-US-352-1154 or SRA-MMB-301 2) Did not discontinue treatment with MMB for any reason while enrolled in Studies GS-US-352-0101, GS-US-352-1214, or GS-US-352-1154 or SRA-MMB-301 3) Any Grade 3 or 4 (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 4) 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 For subjects enrolling for survival follow-up only: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to MMB, its metabolites, or formulation excipient 2) Incomplete recovery from major surgery prior to Day 1 of this study 3) Presence of = Grade 3 (CTCAE Version 4.03) peripheral neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide extended access to momelotinib and assess long-term safety in 4 cohorts of subjects who are currently receiving treatment with MMB and have not experienced progression of disease: - Cohort 1: Study GS-US-352-0101, subjects with PMF or post-PV/ET MF - Cohort 2: Study GS-US-352-1214, subjects with PMF or post-PV/ET MF - Cohort 3: Study GS-US-352-1154, subjects with PMF or post-PV/ET MF - Cohort 4: Study SRA-MMB-301, subjects with PMF or post-PV/ET MF;Secondary Objective: To assess overall survival (OS) and leukemia-free survival (LFS) in all subjects;Primary end point(s): Safety: Incidence, severity, seriousness, and causal relationship of AEs, as defined by CTCAE Version 4.03;Timepoint(s) of evaluation of this end point: From patient enrollment to last dose of MMB plus 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: overall survival (OS) and leukemia-free survival (LFS);Timepoint(s) of evaluation of this end point: Efficacy: from the first dose of study drug to death due to any cause for OS and from the first dose of study drug to any evidence of leukemic transformation and/or death due to any cause for LFS | — |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Denmark, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Netherlands, Poland, Romania, Singapore, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trials Help Desk
GlaxoSmithKline Research & Development Limited
Outcome results
None listed