Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
This is a global, multicenter, 2-part study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-nave 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.
Hematologic,
Phase I
Phase I/III
Adults
Mol. targeted/Immunotherapy/Biologics
Ruxolitinib,
Selinexor (KPT-330),
Selinexor or Placebo
Mohan, Sanjay
International
Vanderbilt University
08-09-2021
Eligibility
18 Years and older
ALL
false
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.
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.
