This study is in progress, not accepting new patients

Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

a study on Myelofibrosis Primary Myelofibrosis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

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.

Official Title

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

Keywords

Myelofibrosis, Selinexor, Ruxolitinib, Janus kinase 2, Myeloproliferative neoplasms, Primary Myelofibrosis, Myeloproliferative Disorders, Selinexor and Ruxolitinib BID, Selinexor 60 mg + Ruxolitinib BID

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 (cm3) .
  • Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (<=) 2.

You CAN'T join if...

  • 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.

Locations

  • UCLA - Satellite Site
    Beverly Hills California 90210 United States
  • UCLA - Satellite Site
    Encino California 93003 United States
  • UCLA
    Los Angles California 90095 United States
  • City of Hope - Irvine Lennar - Satellite
    Irvine California 92618 United States
  • The Oncology Institute of Hope & Innovation
    Pasadena California 91105 United States
  • City of Hope
    Duarte California 91010 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Karyopharm Therapeutics Inc
ID
NCT04562389
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 353 people participating
Last Updated