A Phase 1/3 Study To Evaluate The Efficacy And Safety Of Selinexor, A Selective Inhibitor Of Nuclear Export, In Combination With Ruxolitinib In Treatment-Naïve Patients With Myelofibrosis (SENTRY)

Research summary

This multicenter, 2-part study included a Phase 1, open-label, selinexor dose escalation and expansion part (enrollment completed), and a Phase 3, randomized, double-blind, placebo controlled part to evaluate the efficacy and safety of selinexor + ruxolitinib in treatment naïve patients with MF. Phase 1 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 (Phase 1a) and a dose expansion part (Phase 1b). Phase 3 is the double-blind, randomized, and placebo controlled part of the study comparing the combination of selinexor + ruxolitinib with the combination of placebo + ruxolitinib. As the study has been amended to a Phase 1/3 design, the established selinexor RP2D (60 mg QW) will be evaluated in the Phase 3 part of the study.

Principal Investigator

Prof Adam Mead

Contact us

Email: Latephasehaematology@ouh.nhs.uk

IRAS number

1008333