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CTI BioPharma: PAC203 Ph2 Pacritinib Thrombocytopenia and Primary Myelofibrosis - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out what dose of Pacritinib is the safest and works best for people with PMF, PPV-MF, and PET-MF

What is the Condition Being Studied?

Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) or Post Essential Thrombocythemia Myelofibrosis (PET-MF) that is refractory or resistant to ruxolitinib

Who Can Participate in the Study?

Adults who...
- Have been diagnosed with PMF, PPV-MF, of PET-MF with a DIPSS score of Intermediate 1 or 2, or High Risk
- Have had prior Ruxolitinib treatment failure or intolerance
- Have not had Pacritinib before
- Are not taking any medication that prolongs the QTc interval
- Have not already had (or are planning to have) a stem cell transplant

Age Group
Adults

What is Involved?

If you join this study, you will
- Have a screening period that includes an echocardiogram, ECGs, MRI, blood work, and nightly questionnaires.

- If your platelets are less than 50K during screening you will have weekly blood tests for at least 8 weeks once treatment begins.
- Be randomized (like drawing numbers from a hat) to receive the study drug (Pacritinib) at one of three different doses.
- Take the study drug by mouth once or twice a day as explained by the study doctor for up to 24 weeks

- Have a study visit at the end of weeks 4, 2 and 24 that includes blood tests, a physical exam, an echocardiogram, an MRI every other visit, and ECGs prior to taking the dose of study medication and 4 hours after taking the medication.
- Have an end of treatment visit, and a final visit 30 days after the end of treatment visit.
- Have follow-up visits every 3 months for up to 2.5 years.

Study Details

Full Title
An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis Previously Treated with Ruxolitinib
Principal Investigator
Hematologist
Protocol Number
IRB:PRO00083585
NCT:NCT03165734
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698