A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myel… (NCT03165734) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
United States407 participantsStarted 2017-06-26
Plain-language summary
This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count \<50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients)
Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis
Intervention/treatment: Drug-Pacritinib
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF (as defined by Tefferi and Vardiman 2008)
✓. Platelet count of \<50,000/μL at Screening (Day -35 to Day -3)
✓. Dynamic International Prognostic Scoring System Intermediate-1, Intermediate-2, or High-Risk (Passamonti et al 2010)
✓. Palpable splenomegaly ≥5 cm below the lower costal margin in the midclavicular line as assessed by physical examination
✓. TSS of ≥10 on the MPN-SAF TSS 2.0 or a single symptom score of ≥5 or two symptoms of ≥3, including only the symptoms of left upper quadrant pain, bone pain, itching, or night sweats. The TSS criteria need only to be met on a single day.
✓. Age ≥18 years
✓. Eastern Cooperative Oncology Group performance status 0 to 2
✓. Peripheral blast count of \<10% throughout the Screening period prior to randomization
✕. Completed allogeneic stem cell transplant or are eligible for and willing to complete other approved available therapy including allogeneic stem cell transplant
✕. History of splenectomy or planning to undergo splenectomy
✕. Splenic irradiation within the last 6 months
✕. Previously treated with pacritinib
✕. Treatment with any MF-directed therapy within 14 days prior to treatment Day 1
✕. Prior treatment with more than one JAK2 inhibitor
✕. Prior treatment with with ruxolitinib, if BOTH of the following conditions are met: