Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma
Status:
Unknown status
Trial end date:
2020-07-01
Target enrollment:
Participant gender:
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
Phase:
Phase 2
Details
Lead Sponsor:
Morten Mau-Soerensen
Collaborators:
GSO Global Clinical Research BV Gustave Roussy, Cancer Campus, Grand Paris Hospices Civils de Lyon Institut Curie Karyopharm Therapeutics Inc