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:<ul>
<li>Are diagnosed with myelofibrosis</li>
<li>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</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: quinna.marshburn@duke.edu">quinna.marshburn@duke.edu</a> or 919-668-2556.
<li>Are diagnosed with myelofibrosis</li>
<li>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</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: quinna.marshburn@duke.edu">quinna.marshburn@duke.edu</a> or 919-668-2556.
What is Involved?
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:<ul>
<li>One group will get a 40 mg dose of the study drug</li>
<li>The other group will get a 60 mg dose of the study drug</li></ul>
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:<ul>
<li>Physical exams</li>
<li>Blood draws</li>
<li>Bone marrow biopsies</li>
<li>Imaging (CT or MRI)</li></ul>
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.
<li>One group will get a 40 mg dose of the study drug</li>
<li>The other group will get a 60 mg dose of the study drug</li></ul>
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:<ul>
<li>Physical exams</li>
<li>Blood draws</li>
<li>Bone marrow biopsies</li>
<li>Imaging (CT or MRI)</li></ul>
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
II
Enrollment Status
Open to Enrollment