PACIFICA: Pacritinib vs Physician’s Choice in Myelofibrosis
Research type
Research Study
Full title
A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician’s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/μL)
IRAS ID
281008
Contact name
Adam Mead
Contact email
Sponsor organisation
CTI BioPharma Corp.
Eudract number
2020-000111-69
Duration of Study in the UK
4 years, 1 months, 24 days
Research summary
This Phase 3 study aims to compare the safety and efficacy of pacritinib with physician's choice therapy in patients with myelofibrosis. Pacritinib is a JAK2 inhibitor, a drug class that targets the JAK2 primary pathway within the cells. Many people with myelofibrosis have mutations in this pathway, so researchers want to see if this study drug could help in treating myelofibrosis.
Males and females over the age of 18 are able to participate. Participants could be on the study for a maximum of 30 months once eligibility for the study has been confirmed. There will be a 14 day washout period where current treatments will need to be stopped (28 days for experimental therapies), a treatment period of 24 weeks (including 17 visits) and a post-24 week treatment period of up to 2 years (including monthly visits) where treatment may continue if participants continue to benefit. The study will be conducted worldwide at about 140 study clinics, including approximately 7 centres in the UK, with approximately 348 people participating.
Study participants will be randomly assigned in a 2:1 ratio to receive pacritinib or physician's choice therapy. Participants assigned to the pacritinib treatment group will take two 100 mg capsules of the drug at the same time twice each day, orally, for a total daily dose of 400 mg. The physician's choice treatments will be corticosteroids, hydroxyurea, danazol and low-dose ruxolitinib and participants assigned to receive one of these treatments will take it according to instructions provided by their study doctor.A number of assessments will be performed during the study including physical examinations, blood samples, questionnaires, eDiary completion, electrocardiograms or Multigated Acquisition (MUGA); and Computed Tomography Scans (CT Scans) or Magnetic Resonance Imagine Scans (MRI Scans) to determine disease status.
The study is sponsored by CTI BioPharma Corp.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
20/YH/0200
Date of REC Opinion
28 Aug 2020
REC opinion
Further Information Favourable Opinion