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: 20.0 Level: PT Classification code 10028537 Term: Myelofibrosis System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-004350-42-ES
- Lead Sponsor
- Sierra Oncology, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 200
1) Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, or GS-US-352-1154
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
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 82
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 118
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 <br> Main Objective: To provide extended access to momelotinib in 3 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> ;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 Week 96 or Early Study Drug Discontinuation visit plus 30 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable