drugset
drugset / Trial / NCT03466827

Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma

NCT03466827 ↗

Phase 2 Unknown 25 enrolled Morten Mau-Soerensen GSO Global Clinical Research BV · collabGustave Roussy, Cancer Campus, Grand Paris · collabHospices Civils de Lyon · collabInstitut Curie · collabKaryopharm Therapeutics Inc · collab
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2017-10-12
Primary completion
2020-07-01
Completion
2020-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Selinexor Other / unclassified 60 mg Oral

Indications

thymoma