Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
353actual
Sites
166
Countries
Australia, Belgium, Bulgaria +17
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-03-11 | actual | When the study began enrolling |
| Primary completion | 2026-02-20 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2020-09-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Myelofibrosis
Interventions
- Drug: Selinexor — also filed as KPT-330
- Drug: Selinexor — also filed as KPT-330
- Other: Placebo
- Drug: Ruxolitinib
Primary outcomes
what the primary-completion date above is the date OFPhase 3: Proportion of Participants with Spleen Volume Reduction (SVR) of Greater than or Equal to (>=) 35 Percent (%) (SVR35) at Week 24 Measured by the Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan
measured At Week 24
Phase 3: Absolute mean change in TSS (Abs-TSS) from baseline to Week 24 as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0
measured At Week 24
Phase 1: Maximum Tolerated Dose (MTD)
measured Approximately within the first cycle (28 days) of therapy
Phase 1: Recommended Phase 2 Dose (RP2D)
measured Approximately within the first cycle (28 days) of therapy
Phase 1: Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity
measured From start of drug administration up to 30 days after last dose of study treatment (approximately 48 months)
Publications
- PMID 42227656 — linked by the registry
- PMID 41785311 — linked by the registry
- PMID 39911057 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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