Thymoma Clinical Trial
Official title:
A Phase II Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumour (TET) Progressing After Primary Chemotherapy.
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
Not provided ;
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