Study Comparing Pacritinib Versus Physician's Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia
PACIFICA Phase 3: 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/uL).
About the study
Principal investigator
Dr. Lynda Foltz
MD, FRCPC Co-Head, Division of Hematology, St. Paul’s Hospital Clinical Professor, Department of Medicine, UBC Hematologist, St Paul’s Hospital
Area(s) of medical focus
Blood & Blood Disorders
Cancer & Tumor
Condition(s)
Blood cancers
Period of enrollment
2021-01-01 - 2029-12-31
Participating sites
St. Paul's Hospital
Purpose of trial
The purpose of this study is to find out whether pacritinib works better and is as safe as the drug your physician may choose for participants like you. Pacritinib is a pill that blocks a major driver of myelofibrosis. Pacritinib is an “experimental drug,” which is a drug that is being tested. Health Canada, the regulatory body that oversees the use of natural health products/drugs/devices in Canada, has not approved the sale or use of Pacritinib to treat myelofibrosis, although they have allowed its use in this study. Pacritinib is currently approved by the Food and Drug Administration (FDA) in the US. If you are outside of the United States, pacritinib can only be given in research studies like this one or through other programs allowed by Health Canada.
Eligibility
Key Inclusion Criteria (From ICF):
- Are 18 years of age or older. Dr. Foltz will determine the level of maturity and comprehension of potential study participants 18 years of age before they sign the informed consent form for this study. Only subjects deemed capable of providing consent and signing the main ICF will be consented.
- Are able to understand and sign this informed consent form,
- Have a confirmed diagnosis of myelofibrosis (MF)
- Are not pregnant or nursing, or are not of child-bearing potential, or are of child-bearing potential and you and your partner are willing to avoid pregnancy during this study and for 12 months after the last dose of study drug
Key Exclusion Criteria (From ICF):
- Have had prior splenectomy or planning to undergo splenectomy (a surgical operation involving removal of the spleen)
- Have, in the investigator’s opinion, a concurrent, uncontrolled medical condition which would jeopardize your safety or compliance with the protocol
- Have been treated with any investigational agent within 28 days before the first dose of the study drug
Contact information
Phone number
Phone number
Co-Investigators
Dr. Khaled Ramadan, Dr. Wendy Davis.
Additional Information
Study Phase
Phase 3
Study Type
Drug