Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Thymoma

Thymus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Thoracic Neoplasms

Lymphatic Diseases

Thymic Epithelial Tumor

Selinexor 40 mg oral tablets will be administered twice weekly, either on Monday/Wednesday, Tuesday/Thursday, Wednesday/Friday, Thursday/Saturday, or Friday/Sunday in a 3-weeks-on and 1-week-off schedule.

Open Label Selinexor

Chul Kim, MD

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

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

A Phase 2, Open-label Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumor (TET) Progressing After Primary Chemotherapy (SELECT)

To determine the overall response rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+ PR.

To determine the overall response rate to according to modified ITMIG response criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

To determine six months progression free survival of patients with TET treated with selinexor

To determine overall survival of patients with TET treated with selinexor

The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03

Hackensack Meridian Health

Karyopharm Therapeutics Inc

Georgetown University

Open Label Selinexor 40 mg

Open Label Selinexor: Selinexor 40 mg oral tablets will be administered twice weekly, either on Monday/Wednesday, Tuesday/Thursday, Wednesday/Friday, Thursday/Saturday, or Friday/Sunday in a 3-weeks-on and 1-week-off schedule.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy	NCT03193437	Thymoma Advanced Thymic...	Open Label Seli...	18 Years -	Georgetown University
Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy	NCT03193437	Thymoma Advanced Thymic...	Open Label Seli...	18 Years -	Georgetown University

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