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Amcenestrant · AMEERA-2

Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)

Ensayo de Sanofi en Cancer de mama.

Más ensayos de: Cáncer de mama.

Fase

Fase 1

Estado

Interrumpido

Participantes

10

previstos

Centros

3

Fin del objetivo primario

oct 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en mar 2019.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor decision to prematurely stop the study, not linked to any safety concern.».

Qué mide

Investigational medicinal product (IMP)-related dose limiting toxicities (DLTs) (del registro, en inglés) (del dia 1 al dia 28)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To assess the incidence rate of dose-limiting toxicity and to confirm the recommended dose as well as the maximum tolerated dose of SAR439859 administered as monotherapy to Japanese postmenopausal women with estrogen receptor positive and human epidermal growth factor receptor 2-negative advanced breast cancer. Secondary Objective: * To characterize the overall safety profile of SAR439859 administered as monotherapy. * To characterize the pharmacokinetic profile of SAR439859 administered as monotherapy. * To evaluate the antitumor activity of SAR439859 administered as monotherapy and the clinical benefit rate (complete response, partial response and stable disease ≥ 24 weeks).

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03816839), actualizada en jul 2025.