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

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ClinicalTrials.gov Identifier: NCT03466827
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Collaborators:
Institut Curie
Gustave Roussy, Cancer Campus, Grand Paris
Hospices Civils de Lyon
GSO Global Clinical Research BV
Karyopharm Therapeutics Inc
Information provided by (Responsible Party):
Morten Mau-Soerensen, Rigshospitalet, Denmark

Brief 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

Condition or disease Intervention/treatment Phase
Thymoma Advanced Thymic Epithelial Tumour Drug: Selinexor Phase 2

Detailed Description:
Not provided

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumour (TET) Progressing After Primary Chemotherapy.
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thymus Cancer


Intervention Details:
  • 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.
    Other Name: KPT-330


Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 24 months ]
    To determine the overall response rate according to RECIST 1.1


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 6 months ]
    To determine six months progression free survival of patients with TET treated with selinexor

  2. Adverse Events [ Time Frame: 24 months ]
    The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466827


Contacts
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Contact: Morten Mau-Soerensen, MD, PhD +45 3545 0879 paul.morten.mau-soerensen@regionh.dk
Contact: Kristoffer S Rohrberg, MD, PhD +45 3545 6353 kristoffer.staal.rohrberg@regionh.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Morten Mau-Soerensen, MD, PhD    + 45 3545 0879    morten.mau-soerensen@regionh.dk   
Contact: Kristoffer S Rohrberg, MD, PhD    +45 3545 6353    kristoffer.staal.rohrberg@regionh.dk   
Principal Investigator: Gedske Daugaard, Professor         
France
Hospices Civils de Lyon Not yet recruiting
Lyon, France
Contact: Marylise Ginoux, Professor       marylise.ginoux@chu-lyon.fr   
Principal Investigator: Marylise Ginoux, Professor         
Intitut Curie Not yet recruiting
Paris, France
Contact: Nicolas Girard, Professor       nicolas.girard2@curie.fr   
Principal Investigator: Nicolas Girard, Professor         
Intitut Gustave Roussy Not yet recruiting
Paris, France
Contact: Benjamin Besse, Professor       benjamin.besse@gustaveroussy.fr   
Principal Investigator: Benjamin Besse, Professor         
Sponsors and Collaborators
Morten Mau-Soerensen
Institut Curie
Gustave Roussy, Cancer Campus, Grand Paris
Hospices Civils de Lyon
GSO Global Clinical Research BV
Karyopharm Therapeutics Inc
Investigators
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Study Director: Morten Mau-Soerensen, MD, PhD Rigshospitalet, Denmark

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Responsible Party: Morten Mau-Soerensen, Chief Physician, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03466827     History of Changes
Other Study ID Numbers: TET-SEL
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thymoma
Thymus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases