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ThymomaPhase 2TET-SELNCT03466827

Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma

A Phase 2 study testing Selinexor in people with Thymoma and Advanced Thymic Epithelial Tumour, run by Morten Mau-Soerensen at 4 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thymoma, Advanced Thymic Epithelial Tumour
What is being tested?
Selinexor
Type of treatment
Pill or oral medicine
How many people
25 participants
Where
4 sitesin 2 countries
Study dates
12 Oct 2017to 1 Jul 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 2 countries.

Morten Mau-Soerensen, MD, PhD contact

+45 3545 0879

paul.morten.mau-soerensen@regionh.dk

Kristoffer S Rohrberg, MD, PhD contact

+45 3545 6353

kristoffer.staal.rohrberg@regionh.dk

4 sites in 2 countries

France3 sites, 3 recruiting

  • Hospices Civils de Lyon

    Lyon

    Marylise Ginoux, Professor, marylise.ginoux@chu-lyon.fr

    Marylise Ginoux, Professor

    Not yet recruiting

  • Intitut Curie

    Paris

    Nicolas Girard, Professor, nicolas.girard2@curie.fr

    Nicolas Girard, Professor

    Not yet recruiting

  • Intitut Gustave Roussy

    Paris

    Benjamin Besse, Professor, benjamin.besse@gustaveroussy.fr

    Benjamin Besse, Professor

    Not yet recruiting

Other trials in France

Denmark1 site, 1 recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Morten Mau-Soerensen, MD, PhD, + 45 3545 0879, morten.mau-soerensen@regionh.dk

    Kristoffer S Rohrberg, MD, PhD, +45 3545 6353, kristoffer.staal.rohrberg@regionh.dk

    Recruiting

Other trials in Denmark

About this study

Official title: 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).

Read more

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
Read the detailed description

Not provided

Being tested
Selinexor
Medical subject headings
Thymoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SelinexorDrug

    Also called KPT-330

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    To determine the overall response rate according to RECIST 1.1

    Measured: 24 months

Secondary outcomes (2)

  1. Progression Free Survival

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

    Measured: 6 months

  2. Adverse Events

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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2018
  2. Study start12 Oct 2017
  3. Primary completion1 Jul 2020 (estimated)
  4. Study completion1 Jul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03466827
Sponsor's protocol ID
TET-SEL
Acronym
TET-SEL
Status last verified
Mar 2018
First submitted
9 Mar 2018
Last updated
15 Mar 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selinexor in people with Thymoma and Advanced Thymic Epithelial Tumour, run by Morten Mau-Soerensen at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Morten Mau-Soerensen, MD, PhD (+45 3545 0879, paul.morten.mau-soerensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03466827.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.

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