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INCB057643

Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

Ensayo de INCYTE CORP en Tumor solido.

Más ensayos de: Tumor sólido.

Fase

Fase 1/2

Estado

Interrumpido

Participantes

137

previstos

Centros

18

Fin del objetivo primario

feb 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en may 2016.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Study terminated due to safety issues.».

Qué mide

Number of Participants With Treatment Emergent Adverse Events (TEAE's). (From screening through at least 30 days after end of treatment, up to approximately 24 months) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies. Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety and tolerability of the combination therapy in select advanced solid tumors and hematologic malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic malignancies.

Más ensayos de INCY

Todos los de INCY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02711137), actualizada en oct 2025.