XPORT-MF-034
XPORT-MF-034: Study of Selinexor in Combination with Ruxolitinib in Myelofibrosis (SENTRY)
Trial summary:
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.
Receptor status / problem studied:
Inclusion criteria
1) Aged ≥ 18 years.
2) A diagnosis of primary MF or post-essential thrombocythemia (ET) or postpolycythemia- vera (PV) MF.
3) Active symptoms of MF as determined by presence of at least 2 symptoms using the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0.
4) Participants with international prognostic scoring system (DIPSS) risk category of intermediate-1, or intermediate-2, or high-risk.
5) Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (>=) 450 cubic centimeter (cm^3).
6) Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (<=) 2.
Exclusion criteria
1) More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase).
2) Previous treatment with JAK inhibitors for MF.
3) Previous treatment with selinexor or other XPO1 inhibitors.
Trial Title
XPORT-MF-034
Diagnosis
Myeloproliferative disorders
Type of trial
Pharmaceutical
Type of treatement
Haematology
Phase
III