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Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma

NCT03466827 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-03-15

No results posted yet for this study

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

Conditions

  • Thymoma
  • Advanced Thymic Epithelial Tumour

Interventions

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.

Sponsors & Collaborators

  • Institut Curie

    collaborator OTHER

  • Gustave Roussy, Cancer Campus, Grand Paris

    collaborator OTHER

  • Hospices Civils de Lyon

    collaborator OTHER

  • GSO Global Clinical Research BV

    collaborator OTHER

  • Karyopharm Therapeutics Inc

    collaborator INDUSTRY

  • Morten Mau-Soerensen

    lead OTHER

Principal Investigators

  • Morten Mau-Soerensen, MD, PhD · Rigshospitalet, Denmark

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-12
Primary Completion
2020-07-01
Completion
2020-07-01
FDA Drug
Yes

Countries

  • Denmark
  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03466827 on ClinicalTrials.gov