Calendario›SNY›Amcenestrant · AMEERA-1
Amcenestrant · AMEERA-1
Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer
Ensayo de Sanofi en Cancer de mama.
Más ensayos de: Cáncer de mama.
- Fase
- Fase 1/2
- Estado
- Interrumpido
- Participantes
- 136
- Centros
- 25
- Fin del objetivo primario
- nov 2024
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2017.
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
Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs) (Cycle 1 Day 1 to Cycle 1 Day 28 (cycle duration=28 days)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objectives: Dose Escalation: * To assess the incidence rate of dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) as well as the recommended dose (RD) of amcenestrant administered as monotherapy and in combination with palbociclib * To assess the incidence rate of DLT and determine the RD of everolimus or abemaciclib in combination with the selected amcenestrant dose for the combination therapy Safety Run-In: \- To confirm the RD of amcenestrant in combination with alpelisib Dose Expansion: * Antitumor activity using objective response rate (ORR) * Overall safety profile of amcenestrant administered in combination with palbociclib, alpelisib, everolimus, and abemaciclib Secondary Objectives: * Overall safety profile of amcenestrant monotherapy and in combination * Pharmacokinetic (PK) profile of amcenestrant administered as monotherapy or in combination and PK profile of palbociclib, alpelisib, everolimus and abemaciclib * Antitumor activity using ORR, the clinical benefit rate (CBR) and progression free survival (PFS) * Time to first tumor response * Residual ER availability with positron emission tomography (PET) scan \[(18)F\] fluoroestradiol (18F-FES) uptake with increasing doses of amcenestrant * Food effect on PK of amcenestrant * Potential induction/inhibition effect of amcenestrant on cytochrome P450 (CYP) 3A using 4b-OH cholesterol
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03284957), actualizada en nov 2025.