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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Selinexor 60 mg oral tablets will be administered twice weekly, either Monday/Wednesday or on Tuesday/Thursday or on Wednesday/Friday in a 3-weeks-on and 1-week-off Schedule.
Rigshospitalet
Copenhagen, Denmark
RECRUITINGHospices Civils de Lyon
Lyon, France
NOT_YET_RECRUITINGIntitut Curie
Paris, France
NOT_YET_RECRUITINGIntitut Gustave Roussy
Paris, France
NOT_YET_RECRUITINGOverall Response Rate
To determine the overall response rate according to RECIST 1.1
Time frame: 24 months
Progression Free Survival
To determine six months progression free survival of patients with TET treated with selinexor
Time frame: 6 months
Adverse Events
The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03
Time frame: 24 months
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