Overview

Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy

Status:
Active, not recruiting

Trial end date:
2021-12-01

Target enrollment:

Participant gender:

Summary

The purpose of this study is to evaluate the safety, tolerability and effectiveness of selinexor in patients with advanced thymic epithelial tumor progressing after primary chemotherapy. This is a multicenter, open label phase II trial that uses a Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with at least one platinum containing chemotherapy regimen. This study is comprised of 2 similar phase II trials, one running in US (25 patients) and one running in EU (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:

Georgetown University

Collaborators:

Hackensack Meridian Health
Hackensack University Medical Center
Karyopharm Therapeutics Inc