Calendario›INCY›Epacadostat
Epacadostat
A Study of Atezolizumab in Combination With Epacadostat in Subjects With Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Previously Treated Stage IV Urothelial Carcinoma
Ensayo de INCYTE CORP en NSCLC (Non-small Cell Lung Carcinoma) · UC (Urothelial Cancer) (del registro, en inglés).
- Fase
- Fase 1
- Estado
- Interrumpido
- Participantes
- 29
- Centros
- 6
- Fin del objetivo primario
- nov 2017
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en ene 2015.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.».
Qué mide
Incidence of adverse events (AEs) (Continuously for duration of study participation and up to 42 days after the last dose [approximately 8 months) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study evaluated the safety and tolerability of epacadostat (INCB024360) administered in combination with atezolizumab (MPDL3280A) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that were previously treated with platinum-based chemotherapy and Stage IV urothelial carcinoma who failed a platinum-based chemotherapy regimen. The study was conducted in two phases. The dose escalation phase did utilize a 3 + 3 design to identify the maximum tolerated dose (MTD) or a Pharmacologically Active Dose (PAD) of the combination. This was followed by a dose expansion phase, which was comprised of three cohorts. Expansion Cohorts 1 \& 2 will further evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics at the dose identified in phase one. Expansion Cohort 3 will evaluate the change in biomarker expression following treatment with epacadostat as monotherapy followed by epacadostat and atezolizumab administered in combination.
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Todos los de INCY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02298153), actualizada en abr 2026.