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Alobresib

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 (Alobresib) as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer

Ensayo de GILEAD SCIENCES, INC. en Metastatic Castrate-Resistant Prostate Cancer (del registro, en inglés).

Fase

Fase 1/2

Estado

Interrumpido

Participantes

31

previstos

Centros

4

Fin del objetivo primario

oct 2017

fecha real

Qué significa cada fase y cada estado.

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

Qué mide

Phase 1b Dose Escalation: Number of Participants Experienced Dose Limiting Toxicities (DLTs) (del registro, en inglés) (del dia 1 al dia 28)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study consists of two phases: Dose Escalation (Phase 1b) and Dose Expansion (Phase 2) The Dose Escalation phase will characterize the safety, tolerability, and determine the maximum tolerated dose (MTD) of alobresib as a single agent and in combination with enzalutamide, in participants with metastatic castrate-resistant prostate cancer (mCRPC). The Dose Expansion phase will evaluate the following: * In group 1, the efficacy of alobresib as a single agent in participants with mCRPC who have progressed while receiving enzalutamide (may have also received abiraterone) * In group 2, the efficacy of alobresib combined with enzalutamide in participants with mCRPC who have progressed while receiving treatment with abiraterone (may not have previously received enzalutamide) * In group 3, the efficacy of alobresib combined with enzalutamide in participants with mCRPC who have had prostate specific antigen (PSA) progression, but not radiographic progression, while receiving treatment with enzalutamide (participants may have also previously received abiraterone)

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02607228), actualizada en dic 2020.