Clinical Trial

Myelofibrosis

Study Description

A Phase 2/3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Phase 3 of this study 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/I?L). Approximately 180 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 120 patients) or to P/C therapy (approximately 60 patients) Phase 2 was an open-label, randomized, dose-ranging study designed to identify the most appropriate dosage of pacritinib for future studies based on risk/benefit profile. Patients were randomized 1:1:1 to three dosage arms: 100mg QD, 100mg BID or 200mg BID. A total of 164 patients were randomized in the phase 2 portion of Study PAC203, and 161 (98.2%) patients received any treatment with pacritinib. Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - Pacritinib

Oral administration. Supplied in capsules containing 100 mg (as the free base) in red cap/gray body size 0 opaque hard gelatin capsules. The inactive ingredients are microcrystalline cellulose, magnesium stearate, and polyethylene glycol 8000. Each capsule contains 146 mg of pacritinib citrate, which is equivalent to 100 mg pacritinib free base

Drug - Physician's Choice medications

Physician's Choice medications will be selected and administered according to the investigator's judgement. Investigators can select individual P/C agents but cannot combine agents or give them sequentially.

Additional Information

Official Study Title

A Phase 2/3 Study of Pacritinib 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 Phase 3 Study (PACIFICA):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 Count <50,000/μL)

Clinical Trial ID

NCT03165734

ParticipAid ID

kaz8Yd