Calendario›XBIO›Sodium Cridanimod

Sodium Cridanimod

An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer

Ensayo de Xenetic Biosciences, Inc. en Cancer de endometrio.

Más ensayos de: Cáncer de endometrio.

Fase

Fase 2

Estado

Interrumpido

Participantes

25

previstos

Centros

25

Fin del objetivo primario

jul 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en jun 2017.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The study was discontinued due to a change in development strategy and not due safety concern.».

Qué mide

Overall Disease Control (ODC) as Determined by Radiographic Imaging Measurements (During TP2 Every 12 weeks, until disease progression up to 24 months) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is an open-label, multi-center, single-arm, two-period Phase 2 study. The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with recurrent or persistent endometrial cancer, who have failed progestin monotherapy or who have been identified as Progesterone Receptor (PrR) negative. All patients must have endometrial cancer PrR status determined from an archival sample at Screening. The PrR status (positive or negative) will be determined by central laboratory by ImmunoHistoChemistry (IHC) testing. There are two treatment periods and a follow-up period within the study.

Ficha completa en ClinicalTrials.gov (NCT03077698), actualizada en may 2022.