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
Complete 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
The study is designed to support a pacritinib dosage selection decision. Three dosages will be evaluated, with patients randomized 1:1:1 to pacritinib 100 mg quaque die (QD), pacritinib 100 mg bis in die (BID), or pacritinib 200 mg bis in die (BID). Assigned treatment will continue for 24 weeks unless the patient experiences progressive disease, intolerable AEs, withdraws consent, or until the assigned treatment arm is closed. All patients should complete all visit procedures through Week 24, including patients who stop pacritinib treatment or have protocol-defined progressive disease prior to Week 24, unless patient withdraws consent, dies, undergoes splenic irradiation or splenectomy, or initiates any nonprotocol-directed anti-myelofibrosis treatment. The dosage selection process will be based on pre-specified efficacy and safety parameters, including model-based dose-response. The maximum duration of trial participation for an individual patient will be approximately 7 months. The estimated duration of the entire study is approximately 2 years if the maximum number of patients are enrolled.
** For Eligibility information, please click on the "Look up trial at NIH" link above. **
Other eligibility criteria may apply.
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Myeloproliferative Disorders (MPD); Anemia; Bone Marrow Diseases; Myelofibrosis; Polycythemia; Thrombocythemia; Thrombocythemia, Essential; Hemorrhagic Disorders; Blood Platelet Disorders; Hematologic Diseases
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