Extended Access of Momelotinib for Subjects with Myelofibrosis

Phase 1

• 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-BE
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-16
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion 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) 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified