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
Interventions
Product Name: Momelotinib
Product Code: SRA-0387
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: momelotinib
Other descriptive name: MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
Concentration
Sponsors
Sierra Oncology, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, 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, 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 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 164 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 236
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 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: Not Applicable;Primary end point(s): Incidence and severity 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): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
Public ContactMartha Bond
Sierra Oncology, Inc.
Outcome results
None listed