Last updated: 08/01/2025 08:30:08

Feasibility assessment and indirect comparisons of momelotinib versus (vs) Fedratinib

GSK study ID
219688
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Indirect Treatment Comparisons of Safety Outcomes for Momelotinib vs. Fedratinib in Patients with Myelofibrosis
Trial description: The study will compare safety outcomes between momelotinib versus fedratinib based on Indirect Treatment Comparison (ITCs) in Janus Kinase inhibitor (JAKi)-naive and JAKi-experienced participants with myelofibrosis (MF).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Percentage of JAKi-experienced and JAKi-naive participants with grades 3 or 4 anaemia using National Cancer Institute’s (NCIs) Common Terminology Criteria for Adverse Events (CTCAE)

Timeframe: Up to Week 24

Percentage of JAKi-experienced and JAKi-naive participants with grades 3 or 4 thrombocytopenia using NCI CTCAE

Timeframe: Up to Week 24

Secondary outcomes:

Percentage of JaKi-experienced and JAKi-naive participants with anaemia (all grades) using NCI CTCAE

Timeframe: Up to Week 24

Percentage of JAKI-experienced and JAKi-naive participants thrombocytopenia (all grades) using NCI CTCAE

Timeframe: Up to Week 24

Percentage of JAKI-experienced and JAKi-naive participants with a serious adverse event

Timeframe: Up to Week 24

Percentage of JAKi-experienced and JAKi-naive participants with at a serious adverse event leading to treatment discontinuation

Timeframe: Up to Week 24

Percentage of JAKi-experienced and JAKi-naive participants with at a serious adverse event leading to a treatment dose reduction

Timeframe: Up to Week 24

Percentage of JAKi-experienced and JAKi-naive participants with at least one grade 3 or grade 4 adverse event

Timeframe: Up to Week 24

Percentage of JAKi-experienced participants with headache (all grades) using NCI CTCAE

Timeframe: up to Week 24

Percentage of JAKi-naive participants with grades 3 or 4 headache using NCI CTCAE

Timeframe: Up to Week 24

Percentage of JAKi-experienced and JAKi-naive participants with diarrhea (all grades) NCI CTCAE

Timeframe: Up to Week 24

Percentage of JAKi-experienced participants with dizziness (all grades) NCI CTCAE

Timeframe: Up to Week 24

Percentage of JAKi-naive participants with grades 3 or 4 dizziness using NCI CTCAE

Timeframe: Up to Week 24

Percentage of JAKi-experienced and JAKi-naive participants with abdominal pain (all grades) using NCI CTCAE

Timeframe: Up to Week 24

Percentage of JAKi-experienced and JAKi-naive participants with nausea (all grades) using NCI CTCAE

Timeframe: Up to Week 24

Percentage of JAKi-experienced and JAKi-naive participants with fatigue (all grades) using NCI CTCAE

Timeframe: Up to Week 24

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-14-02
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Cho S, Conlon S, Ellis C, Gorsh B, Harrison C, Masarova L, et al. . Indirect treatment comparison of momelotinib vs fedratinib safety in patients with myelofibrosis. Future Oncol. PMID: 40476514 DOI: 10.1080/14796694.2025.2511564
Medical condition
Neoplasms, Primary Myelofibrosis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
December 2022 to February 2023
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • This analysis will use data from the Simplify-1 (NCT01969838), Simplify-2 (NCT02101268) and Momentum (NCT04173494) trial populations.
Inclusion and exclusion criteria
Inclusion criteria:
  • This analysis will use data from the Simplify-1 (NCT01969838), Simplify-2 (NCT02101268) and Momentum (NCT04173494) trial populations.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2023-14-02
Actual study completion date
2023-14-02

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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