Phase II clinical trial - Appareil pulmonaire

TET-SEL
Appareil pulmonaire
Essai clinique fermé
Public cible
Adulte
A Phase II Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumour (TET) Progressing After Primary Chemotherapy.
Description de l'essai

The aim of the study is to determine the efficacy of selinexor in adults with TETs determined by overall response rate (RECIST 1.1) in two parallel cohorts of patients with advanced thymomas or thymic carcinomas. The study is an international, multicenter, open label phase II trial using Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with least one platinum containing chemotherapy regimen.;This study is comprised of 2 similar phase II tirals, one running in EU (25 patients) and one running in US (25 patients).