Spots Global Cancer Trial Database for Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy
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Trial Identification
Brief Title: Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy
Official Title: A Phase 2, Open-label Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumor (TET) Progressing After Primary Chemotherapy (SELECT)
Study ID: NCT03193437
Interventions
Study Description
Brief 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
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States
John Theurer Cancer Center - Hackensack University Medical Center, Hackensack, New Jersey, United States
Contact Details
Name: Chul Kim, MD
Affiliation: Georgetown University
Role: STUDY_CHAIR
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