Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma (TET-SEL)

March 9, 2018 updated by: Morten Mau-Soerensen

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Not provided

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
  • France
      • Lyon, France
        • Not yet recruiting
        • Hospices Civils de Lyon
        • Contact:
        • Principal Investigator:
          • Marylise Ginoux, Professor
      • Paris, France
        • Not yet recruiting
        • Intitut Curie
        • Contact:
        • Principal Investigator:
          • Nicolas Girard, Professor
      • Paris, France
        • Not yet recruiting
        • Intitut Gustave Roussy
        • Contact:
        • Principal Investigator:
          • Benjamin Besse, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed advanced TET (thymoma or thymic carcinoma)
  • Inoperable per local Investigator (Masaoka Stage III or IV)
  • Progression after treatment with least one platinum containing chemotherapyregimen
  • Measurable disease (RECIST 1.1)
  • Age ≥18 years
  • ECOG PS <2
  • Patients must have recovered from the toxic effects of prior therapy at the time of initiation of the study drug unless toxicity is stable.
  • A 4 weeks interval from any investigational agents or cytotoxic chemotherapy to start of study is required
  • Signed informed consent

  • Adequate bone marrow function and organ function:

    • Hematopoietic function: total white blood cell count (WBC) ≥ 3000/mm³, absolute neutrophil count (ANC) ≥ 1500/mm³, platelet count ≥ 100,000/mm²
    • Hepatic function: bilirubin < 1.5 times the upper limit of normal (ULN), ALT < 2.5 times ULN or ALT < 5.0 times ULN in the presence of liver metastases
    • Creatinine clearance > 30 ml/min according to Cockcroft-Gault
  • Patients of childbearing potential must agree to use adequate birth control during and for 3 months after participation in this study

Exclusion Criteria:

  • No significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy, including

    • Unstable cardiovascular function
    • Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen)
    • Markedly decreased visual acuity
    • Active infection requiring intravenous antibiotics
  • Pregnancy or breast-feeding
  • Symptomatic brain metastasis requiring corticosteroids
  • Uncontrolled autoimmune disorders. Patients with autoimmune disorders under control on medication may be included. Patients with pure red cell aplasia may be included if haemoglobin levels are relatively stable on transfusions or medication
  • Any other cancer (excluding radically operated localised squamous skin cancer) with clinical activity within the last 2 years
  • Significantly diseased or obstructed gastrointestinal tract, malabsorption, uncontrolled vomiting or diarrhea or inability to swallow oral medications
  • No dehydration of NCI-CTCAE grade ≥ 1
  • Serious psychiatric or medical conditions that could interfere with treatment.
  • No history of organ allograft
  • No concurrent therapy with approved or investigational anticancer therapeutics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: 24 months
To determine the overall response rate according to RECIST 1.1
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 6 months
To determine six months progression free survival of patients with TET treated with selinexor
6 months
Adverse Events
Time Frame: 24 months
The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Morten Mau-Soerensen

Collaborators

Hospices Civils de Lyon
Gustave Roussy, Cancer Campus, Grand Paris
Institut Curie
Karyopharm Therapeutics Inc
GSO Global Clinical Research BV

Investigators

  • Study Director: Morten Mau-Soerensen, MD, PhD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2017

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

March 9, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

March 15, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TET-SEL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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