Karyopharm: Phase 1/3 study of selinexor in combo with rux (Myelofibrosis)

Purpose of this Study

We are doing this study to find the most effective, safe dose of an experimental drug called selinexor (the study drug). We want to know how well this study drug works in people with myelofibrosis when it is given in combination with a drug called ruxolitinib.

Who Can Participate?

Eligibility

Adults ages 18+ who are diagnosed with one of the following:
  • Primary myelofibrosis; OR
  • Post-essential thrombocythemia; OR
  • Post-polycythemia-vera
Eligible candidates must also:
  • Have measurable splenomegaly during the screening period (at least 450 cm3 by MRI or CT scan)
  • Have not received previous treatment with JAK inhibitors for MF
  • Have not received previous treatment with selinexor or other XPO1 inhibitors
For more information about who can join this study, please contact the study team at 919-660-7262.

What is Involved?

Description

If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
  • Have a physical exam
  • Have a heart scan (ECG)
  • Have blood draws
  • Answer questionnaires
If you are eligible to join the study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
  • One group will get the study drug in combination with ruxolitinib
  • The other group will get the study drug in combination with a placebo (inactive substance that has no medicine)
Both the study drug and ruxolitinib are tablets that you take by mouth. You will take the study drug regimen every day during the study's dosing period. You will come in for a thorough exam around 30 days after you stop taking your assigned study regimen. Your participation in the study will last for up to 3 years.

Study Details

Full 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

Principal Investigator

Lindsay
Rein

Protocol Number

PRO00113572

NCT ID

NCT04562389

Phase

III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov