Karyopharm:Phase 2 Selinexor monotherapy with JAK inhibitor-naive myelofibrosis and thrombocytopenia

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) for people with myelofibrosis (MF).

Who Can Participate?

Eligibility

Adults ages 18+ who:

Are diagnosed with myelofibrosis
Have measurable splenomegaly during the screening period that is defined as a volume of at least 450 cubic centimeters according to MRI or CT scan

For more information about who can join this study, please contact the study team at quinna.marshburn@duke.edu or 919-668-2556.

What is Involved?

Description

If you decide to participate in this study, you will have a screening visit to see if you are eligibile to join. If you meet the criteria, you will be get a random assignment (like a coin flip) to 1 of 2 groups:

One group will get a 40 mg dose of the study drug
The other group will get a 60 mg dose of the study drug

The study drug is a tablet that you take by mouth once per week. Other optional co-therapies (ruxolitinib or pacritinib or momelotinib) may be added to your study drug regimen if you meet certain lab and imaging criteria. All of these drugs are approved treatments for MF. The following tests and procedures will be performed throughout the study:

Physical exams
Blood draws
Bone marrow biopsies
Imaging (CT or MRI)

You will continue taking the study drug regimen for as long as you and your study doctor believe that you are getting a benefit. Participation in the study can last for up to 3 years.

Study Details

Full Title

A Phase 2 study to evaluate the efficacy and safety of selinexor monotherapy in subjects with JAK inhibitor-naïve myelofibrosis and moderate thrombocytopenia

Principal Investigator

Lindsay

Rein

Protocol Number

PRO00115353

NCT ID

NCT05980806

Phase

Enrollment Status

Open to Enrollment

ClinicalTrials.gov