Calendario›INCY›Ruxolitinib

Ruxolitinib

Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF)

Ensayo de INCYTE CORP en Mielofibrosis.

Más ensayos de: Mielofibrosis.

Fase

Fase 1

Estado

Completado

Participantes

69

previstos

Centros

18

Fin del objetivo primario

dic 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en mar 2011.

Qué mide

Number of Participants With Dose Limiting Toxicities (del registro, en inglés) (28 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib in patients with myelofibrosis (MF). The study consists of two periods: the core study period, comprising the dose escalation stage and the safety extension phase up to Week 24, then the extension study period beyond Week 24 and up to 3 years, to further characterize the safety and efficacy of ruxolitinib in this patient population. The dose escalation phase will enroll successive cohorts of patients who receive increasing doses of ruxolitinib until the maximum safe starting dose (MSSD) is determined. In the safety expansion phase, additional patients will be treated with ruxolitinib at the MSSD defined during dose escalation. The primary objective is to establish the MSSD of ruxolitinib in patients with MF and starting platelet counts \< 100 x 10 \^9/L

Más ensayos de INCY

Todos los de INCY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01317875), actualizada en ago 2025.