Study of Selinexor in Combination with Ruxolitinib in Myelofibrosis
Sponsor: Karyopharm Therapeutics Inc
ClinicalTrials ID:NCT04562389
This global study evaluates selinexor plus ruxolitinib in JAKi-naïve myelofibrosis patients. Phase 1 determined safety and dosage; Phase 3 compares efficacy with placebo. Eligible participants have specific MF diagnoses, measurable splenomegaly, and meet health criteria. Interventions include selinexor (40/60 mg QW), placebo, and ruxolitinib (15/20 mg BID).
Patient Parameters
| Parameter | Options |
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Program Overview
This is a global, multicenter, 2-part study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended Phase 2 dose (RP2D) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). Phase 3 (ongoing), double-blind, placebo-controlled part of the study comparing the efficacy and safety of combination therapy of selinexor + ruxolitinib with combination of placebo + ruxolitinib.
Eligibility Criteria
Inclusion Criteria
- Aged ≥ 18 years
- A diagnosis of primary MF or post-essential thrombocythemia (ET) or postpolycythemia- vera (PV) MF.
- Active symptoms of MF as determined by presence of at least 2 symptoms using the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0.
- Participants with international prognostic scoring system (DIPSS) risk category of intermediate-1, or intermediate-2, or high-risk.
- Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (>=) 450 cubic centimeter (cm^3) .
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (<=) 2.
Exclusion Criteria
- More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase).
- Previous treatment with JAK inhibitors for MF.
- Previous treatment with selinexor or other XPO1 inhibitors.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UAB Division of Hematology/Oncology | 35294 | Birmingham | Alabama |
| UCLA - Satellite Site | 90210 | Beverly Hills | California |
| City of Hope | 91010 | Duarte | California |
| UCLA - Satellite Site | 93003 | Encino | California |
| City of Hope - Irvine Lennar - Satellite | 92618 | Irvine | California |
| UCLA | 90095 | Los Angles | California |
| The Oncology Institute of Hope & Innovation | 91105 | Pasadena | California |
| USOR - Rocky Mountain Cancer Centers - Aurora | 80045 | Aurora | Colorado |
| Smilow Cancer Hospital - New Haven | 06511 | New Haven | Connecticut |
| Norton Cancer Institute - Saint Matthews | 40207 | Louisville | Kentucky |
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