Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called INCB000928 (the study drug). We want to know how well this study drug works alone and in combination with ruxolitinib in people with anemia due to myeloproliferative disorders.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with MF who are transfusion dependent have symptomatic anemia</li>
<li>Have failed previous treatment with JAK inhibitors or are unable/ineligible to receive a JAK inhibitor treatment</li>
<li>Have been on a therapeutic and stable regimen of ruxolitinib for at least 12 consecutive weeks before joining the study</li>
<li>Are not a candidate for stem cell transplantation</li></ul>
For more information about who can join this study, please contact the study team at 919-660-7262.
<li>Are diagnosed with MF who are transfusion dependent have symptomatic anemia</li>
<li>Have failed previous treatment with JAK inhibitors or are unable/ineligible to receive a JAK inhibitor treatment</li>
<li>Have been on a therapeutic and stable regimen of ruxolitinib for at least 12 consecutive weeks before joining the study</li>
<li>Are not a candidate for stem cell transplantation</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>Have a bone marrow biopsy/aspiration</li>
<li>Have the spleen measured by palpitation</li>
<li>Have a scan of abdomen & pelvis</li></ul>
After the screening period, you will enter the study drug period. You will be on the study drug for about 12 months, with an additional year of follow-up. You may remain on study drug for as long as you and your study doctor feel you are benefitting from it.
You will take the study drug or the study drug + ruxolitinib in continuous 28-day (4 week) cycles. You will have assessments done at the end of each cycle to see how you are doing. Both the study drug and ruxolitinib are taken by mouth.
You will visit us for a follow-up visit and thorough exam about 30 days after you stop taking the study drug.
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li>
<li>Have a bone marrow biopsy/aspiration</li>
<li>Have the spleen measured by palpitation</li>
<li>Have a scan of abdomen & pelvis</li></ul>
After the screening period, you will enter the study drug period. You will be on the study drug for about 12 months, with an additional year of follow-up. You may remain on study drug for as long as you and your study doctor feel you are benefitting from it.
You will take the study drug or the study drug + ruxolitinib in continuous 28-day (4 week) cycles. You will have assessments done at the end of each cycle to see how you are doing. Both the study drug and ruxolitinib are taken by mouth.
You will visit us for a follow-up visit and thorough exam about 30 days after you stop taking the study drug.
Study Details
Full Title
A Phase 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
Principal Investigator
Lindsay
Rein
Protocol Number
PRO00112838
NCT ID
NCT04455841
Phase
I/II
Enrollment Status
Open to Enrollment