Last updated: 07/17/2025 06:00:09

Comparisons of Momelotinib versus (vs) Pacritinib in Myelofibrosis Participants

GSK study ID
220048
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 Momelotinib vs. Pacritinib in Myelofibrosis Patients
Trial description: This study will compare the safety outcomes between momelotinib vs pacritinib 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-naive and JAKi-experienced participants with grades 3 or 4 anemia using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) criteria

Timeframe: Up to Week 24

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

Timeframe: Up to Week 24

Secondary outcomes:

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

Timeframe: Up to Week 24

Percentage of non- Transfusion-Independent (TI) patients at baseline achieving transfusion independence according to Gale criteria

Timeframe: Up to Week 24

Percentage of non-TI patients at baseline achieving transfusion independence according to SIMPLIFY-like criteria

Timeframe: Up to Week 24

Number of participants achieving TI according to Gale criteria

Timeframe: From Week 12 to Week 24

Percentage of non-TI patients at baseline achieving a ≥50% transfusion reduction according to Gale criteria

Timeframe: From Week 12 to Week 24

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-11-07
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Liu T, Masarova L, Purser M, Zhang W. . Indirect treatment comparisons of momelotinib vs pacritinib safety and anemia outcomes in patients with myelofibrosis. Future Oncol. PMID: 40476686 DOI: 10.1080/14796694.2025.2511562
Medical condition
Neoplasms, Primary Myelofibrosis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
February 2023 to July 2023
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18 Years - NA Not applicable (No limit)
Accepts healthy volunteers
No
  • This analysis will use data from the SIMPLIFY-1 (NCT03165734), SIMPLIFY-2 (NCT02101268), MOMENTUM trial (NCT04173494), PERSIST-2 (NCT02055781) and PAC203 (NCT03165734)
Inclusion and exclusion criteria
Inclusion criteria:
  • This analysis will use data from the SIMPLIFY-1 (NCT03165734), SIMPLIFY-2 (NCT02101268), MOMENTUM trial (NCT04173494), PERSIST-2 (NCT02055781) and PAC203 (NCT03165734)

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
2023-11-07
Actual study completion date
2023-11-07

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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