Calendario›GILD›GS-5829

GS-5829

GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer

Ensayo de GILEAD SCIENCES, INC. en Advanced Estrogen Receptor Positive HER2- Breast Cancer (del registro, en inglés).

Fase

Fase 1/2

Estado

Interrumpido

Participantes

14

previstos

Centros

6

Fin del objetivo primario

jul 2018

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en ene 2017.

Qué mide

Phase 1b Dose Escalation: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) Through Day 28 at Each Dose Level of GS-5829 (Baseline up to 28 days) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objectives of the Phase 1b Dose Escalation part of this study are to characterize the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant and to determine the maximum tolerated dose (MTD) or the recommended Phase 2 dose of GS-5829 in combination with fulvestrant in women with advanced estrogen receptor positive, HER2-negative (ER+/HER2-) breast cancer. The primary objective of the Randomized Phase 2 Dose Expansion portion of this study is to evaluate the efficacy of GS-5829 in combination with fulvestrant compared to fulvestrant alone in women with advanced ER+/HER2- breast cancer. This study was terminated early and the Phase 2 portion of the study was not conducted.

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02983604), actualizada en jul 2019.