Extended Access of Momelotinib for Subjects with Myelofibrosis
- Conditions
- Primary Myelofibrosis (PMF), Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)MedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-004350-42-DE
- Lead Sponsor
- GlaxoSmithKline Research @ Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
For subjects continuing MMB treatment:
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 SRAMMB-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:
Participating in survival follow-up after discontinuation of treatment in study SRA-MMB-301
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>- Cohort 1: Study GS-US-352-0101, subjects with PMF or post-PV/ET MF<br>- Cohort 2: Study GS-US-352-1214, subjects with PMF or post-PV/ET MF<br>- Cohort 3: Study GS-US-352-1154, subjects with PMF or post-PV/ET MF<br>- 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: Safety: From patient enrollment to last dose of MMB plus 30 days
- Secondary Outcome Measures
Name Time Method 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