Determining the recommended dose of pacritinib: results from the PAC203 dose-finding trial in advanced myelofibrosis
| Autor: | Adam R. Craig, Valentín García-Gutiérrez, Carole B. Miller, Adam J. Mead, Alessandro M. Vannucchi, Stephen T. Oh, Diane R. Mould, Miklos Egyed, John Mascarenhas, Raajit K. Rampal, Michael R. Savona, Sri Devineni, Kaori Ito, Jean-Jacques Kiladjian, Aaron T. Gerds, Claire N. Harrison, Jeanne Palmer, Karisse Roman-Torres, Shanthakumar Tyavanagimatt, Moshe Talpaz, Jennifer O'Sullivan, Prithviraj Bose, Sarah A. Buckley, Bart L. Scott, Abdulraheem Yacoub, Jennifer A. Smith |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Bridged-Ring Compounds
medicine.medical_specialty Ruxolitinib business.industry Anemia Clinical Trials and Observations Phases of clinical research Hematology medicine.disease Gastroenterology Pacritinib Pyrimidines Treatment Outcome Pharmacokinetics Primary Myelofibrosis Internal medicine Pharmacodynamics medicine Humans business Adverse effect Myelofibrosis medicine.drug |
| Zdroj: | Blood Adv |
| Popis: | PAC203 is a randomized dose-finding study of pacritinib, an oral JAK2/IRAK1 inhibitor, in patients with advanced myelofibrosis who are intolerant of or resistant to ruxolitinib. Patients were randomized 1:1:1 to pacritinib 100 mg once per day, 100 mg twice per day, or 200 mg twice per day. Enhanced eligibility criteria, monitoring, and dose modifications were implemented to mitigate risk of cardiac and hemorrhagic events. Efficacy was based on ≥35% spleen volume response (SVR) and ≥50% reduction in the 7-component total symptom score (TSS) through week 24. Of 161 patients, 73% were intolerant of and 76% had become resistant to ruxolitinib; 50% met criteria for both. Severe thrombocytopenia (platelet count |
| Databáze: | OpenAIRE |
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