Extended Access of Momelotinib for Subjects with Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
- Conditions
- Primary Myelofibrosis or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis10028389
- Registration Number
- NL-OMON52629
- Lead Sponsor
- Sierra Oncology, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
Eligibility Criteria 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 SRA-MMB-301
3) Negative serum or urine pregnancy test is required for female subjects of
childbearing potential as described in Appendix 3
4) Male subjects and female subjects of childbearing potential who engage in
heterosexual intercourse must agree to use protocol specified method(s) of
contraception as described in Appendix 3
5) 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 the last MMB administration to
Day 1 of this study
6) Any adverse event (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
7) Ability and agreement to attend protocol-specified visits at the study site
8) Able to comprehend and willing to sign the informed consent form
Eligibility Criteria for Subjects Enrolling for Survival Follow-Up Only:
1) Participating in survival follow-up after discontinuation of treatment in
study SRA-MMB-301
1) Known hypersensitivity to MMB, its metabolites, or formulation excipients
2) Incomplete recovery from major surgery prior to Day 1 of this study
3) Pregnant or lactating females
4) Presence of * Grade 3 (CTCAE Version 4.03) peripheral neuropathy
5) Known positive status for human immunodeficiency virus (HIV)
6) Known chronic active or acute viral hepatitis A, B, or C infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety: Safety will be evaluated by the incidence, severity, seriousness, and<br /><br>causal relationship of AEs.<br /><br>Efficacy: Survival will be evaluated overall and as leukemia-free (evidence of<br /><br>leukemic transformation or death).<br /><br>Pharmacokinetics: None</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>