Spots Global Cancer Trial Database for Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma

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Trial Identification

Brief Title: Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma

Official Title: A Phase II Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumour (TET) Progressing After Primary Chemotherapy.

Study ID: NCT03466827

Conditions

Thymoma

Advanced Thymic Epithelial Tumour

Interventions

Selinexor

Study Description

Brief Summary: 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). There are two study arms: Arm A: Thymoma * Stage 1: 15 patients * Stage 2: 10 patients Arm B: Thymic carcinoma * Stage 1: 15 patients * Stage 2: 10 patients

Detailed Description: Not provided