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Itacitinib

Itacitinib Combined With INCB024360 and/or Itacitinib Combined With INCB050465 in Advanced Solid Tumors

Ensayo de INCYTE CORP en Tumor solido.

Más ensayos de: Tumor sólido.

Fase

Fase 1

Estado

Interrumpido

Participantes

142

previstos

Centros

11

Fin del objetivo primario

sep 2018

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en nov 2015.

Qué mide

Number of Participants With Dose Limiting Toxicities (DLTs) (del registro, en inglés) (del inicio a los 21 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid tumors. The study will be divided into 3 parts (Part 1a, Part 1b, and Part 2). Part 1a will evaluate a JAK inhibitor with JAK1 selectivity (Itacitinib) in combination with an IDO1 inhibitor (epacadostat; INCB024360; Group A) and Itacitinib in combination with a PI3K-delta inhibitor (INCB050465; Group B) to determine the MTD or PAD and the recommended Part 1b doses for each combination. Once the recommended dose has been identified for each treatment group in Part 1a, subjects with advanced solid tumors will be enrolled into expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b). In Part 2, additional expansion cohorts will be enrolled to further evaluate lower doses of itacitinib and INCB050465 in subjects with select tumor types.

Más ensayos de INCY

Todos los de INCY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02559492), actualizada en sep 2019.