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
Aged 18 years
A diagnosis of primary MF or post-essential thrombocythemia (ET) or postpolycythemia- vera (PV) MF.
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.
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.
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) .
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.
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).
More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase).
Previous treatment with JAK inhibitors for MF.
Previous treatment with JAK inhibitors for MF.
Previous treatment with selinexor or other XPO1 inhibitors.
Previous treatment with selinexor or other XPO1 inhibitors.
Aged 18 years
Aged 18 years
A diagnosis of primary MF or post-essential thrombocythemia (ET) or postpolycythemia- vera (PV) MF.
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.
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.
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) .
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.
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).
More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase).
Previous treatment with JAK inhibitors for MF.
Previous treatment with JAK inhibitors for MF.
Previous treatment with selinexor or other XPO1 inhibitors.
Previous treatment with selinexor or other XPO1 inhibitors.
