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Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Trial Status: closed to accrual
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.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT04562389.
