A Phase 1/3 Study to Evaluate Efficacy and Safety of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination With Ruxolitinib in Treatment-naïve Patients With Myelofibrosis
A Phase 1/3 Study to Evaluate Efficacy and Safety of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination With Ruxolitinib in Treatment-naïve Patients With Myelofibrosis
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:
Exclusion Criteria:
Los Angles, California 90095, United States
Hackensack, New Jersey 07601, United States
Columbus, Ohio 43210, United States
Wheeling, West Virginia 26003, United States
Sofia, 1797, Bulgaria
Stara Zagora, 6003, Bulgaria
Saint-Priest-en-Jarez, Pays de la Loire Region 42271, France
Ioánnina, Thessaly 455 00, Greece
Ramat Gan, Central District 5265601, Israel
Catania, Catania 95123, Italy
Milan, Milan 20162, Italy
Torino, Turin 10126, Italy
Bologna, 40138, Italy
Torun, Kuyavian-Pomeranian Voivodeship 87-100, Poland
Wroclaw, Lower Silesian Voivodeship 53-439, Poland
Brzozów, Podkarpackie Voivodeship 36-200, Poland
Wałbrzych, Silesian Voivodeship 58-309, Poland