Clinical Trial TitleAn open-label, randomized, phase 2 dose-finding study of pacritinib in patients with thrombocytopenia and primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis previously treated with ruxolitinib.
Clinical Trial Protocol Description:
The purpose of this study is to find out what dose of pacritinib is safest and works best for people with myelofibrosis who were previously treated with ruxolitinib. Subjects will be assigned to one of 3 dosage levels. Pacritinib is taken by mouth one to two times daily. Subjects would take pacritinib for a maximum of 8 months.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.
- Have failed therapy with ruxolitinib on the basis of intolerance or loss of efficacy.
- Have thrombocytopenia (platelet count of ≤100,000/μL).
- Have splenomegaly.
You will be excluded from the study if any of the following criteria apply to you:
- Have completed allogeneic stem cell transplantation (ASCT) or are eligible for and willing to complete an allogeneic stem cell transplantation (ASCT).
- Have a history of splenectomy or planning to undergo splenectomy.
- Have splenic irradiation within the last 6 months.
- Have previously been treated with pacritinib.
This is a partial list of inclusion and exclusion criteria.