NCT03466827

Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma

A Phase II Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumour (TET) Progressing After Primary Chemotherapy.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Morten Mau-Soerensen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Not provided

Conditions

• Thymoma
• Advanced Thymic Epithelial Tumour

Interventions

Type	Name	Description
DRUG	Selinexor	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.

Timeline

• Start date: 2017-10-12
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2018-03-15
• Last updated: 2018-03-15

Locations

4 sites across 2 countries: Denmark, France

Regulatory

• FDA-regulated drug study