Calendario›INCY›INCB024360

INCB024360

A Dose-escalation Study in Subjects With Advanced Malignancies

Ensayo de INCYTE CORP en Solid Tumors and Hematologic Malignancy (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

52

previstos

Centros

2

Fin del objetivo primario

may 2013

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en jul 2010.

Qué mide

Safety and tolerability as measured by adverse events and dose limiting toxicities (Measured from baseline through follow-up period (measured during cycle 1 weekly and bi monthly thereafter)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is an open label, dose escalation study using a 3 + 3 design to determine if INCB024360 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. For subject safety, the first subject in each cohort will be administered drug for one week before the next two subjects in the cohort can begin drug administration. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects. An expanded cohort of up to 15 patients may be recruited to further explore safety at the 'maximum tolerated dose' or at a lower, pharmacologically active, dose.

Más ensayos de INCY

Todos los de INCY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01195311), actualizada en ene 2018.