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:<ul>
<li>Primary myelofibrosis; OR</li>
<li>Post-essential thrombocythemia; OR</li>
<li>Post-polycythemia-vera</li></ul>
Eligible candidates must also:<ul>
<li>Have measurable splenomegaly during the screening period (at least 450 cm3 by MRI or CT scan)</li>
<li>Have not received previous treatment with JAK inhibitors for MF</li>
<li>Have not received previous treatment with selinexor or other XPO1 inhibitors</li></ul>
For more information about who can join this study, please contact the study team at 919-660-7262.
<li>Primary myelofibrosis; OR</li>
<li>Post-essential thrombocythemia; OR</li>
<li>Post-polycythemia-vera</li></ul>
Eligible candidates must also:<ul>
<li>Have measurable splenomegaly during the screening period (at least 450 cm3 by MRI or CT scan)</li>
<li>Have not received previous treatment with JAK inhibitors for MF</li>
<li>Have not received previous treatment with selinexor or other XPO1 inhibitors</li></ul>
For more information about who can join this study, please contact the study team at 919-660-7262.
What is Involved?
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:<ul>
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li>
<li>Answer questionnaires</li></ul>
If you are eligible to join the study, you will get a random assignment (like a coin flip) to 1 of 2 groups:<ul>
<li>One group will get the study drug in combination with ruxolitinib</li>
<li>The other group will get the study drug in combination with a placebo (inactive substance that has no medicine)</li></ul>
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.
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li>
<li>Answer questionnaires</li></ul>
If you are eligible to join the study, you will get a random assignment (like a coin flip) to 1 of 2 groups:<ul>
<li>One group will get the study drug in combination with ruxolitinib</li>
<li>The other group will get the study drug in combination with a placebo (inactive substance that has no medicine)</li></ul>
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