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

Primary Purpose

Thymoma, Advanced Thymic Epithelial Tumour

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Selinexor
Sponsored by
Morten Mau-Soerensen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thymoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RigshospitaletRecruiting
  • Hospices Civils de Lyon
  • Intitut Curie
  • Intitut Gustave Roussy

Outcomes

Primary Outcome Measures

Overall Response Rate
To determine the overall response rate according to RECIST 1.1

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2018
Last Updated
March 9, 2018
Sponsor
Morten Mau-Soerensen
Collaborators
Institut Curie, Gustave Roussy, Cancer Campus, Grand Paris, Hospices Civils de Lyon, GSO Global Clinical Research BV, Karyopharm Therapeutics Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03466827
Brief Title
Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma
Acronym
TET-SEL
Official Title
A Phase II Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumour (TET) Progressing After Primary Chemotherapy.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Morten Mau-Soerensen
Collaborators
Institut Curie, Gustave Roussy, Cancer Campus, Grand Paris, Hospices Civils de Lyon, GSO Global Clinical Research BV, Karyopharm Therapeutics Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Not provided

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma, Advanced Thymic Epithelial Tumour

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Selinexor
Other Intervention Name(s)
KPT-330
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
To determine the overall response rate according to RECIST 1.1
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
To determine six months progression free survival of patients with TET treated with selinexor
Time Frame
6 months
Title
Adverse Events
Description
The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morten Mau-Soerensen, MD, PhD
Phone
+45 3545 0879
Email
paul.morten.mau-soerensen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Kristoffer S Rohrberg, MD, PhD
Phone
+45 3545 6353
Email
kristoffer.staal.rohrberg@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten Mau-Soerensen, MD, PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten Mau-Soerensen, MD, PhD
Phone
+ 45 3545 0879
Email
morten.mau-soerensen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Kristoffer S Rohrberg, MD, PhD
Phone
+45 3545 6353
Email
kristoffer.staal.rohrberg@regionh.dk
First Name & Middle Initial & Last Name & Degree
Gedske Daugaard, Professor
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marylise Ginoux, Professor
Email
marylise.ginoux@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Marylise Ginoux, Professor
Facility Name
Intitut Curie
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Girard, Professor
Email
nicolas.girard2@curie.fr
First Name & Middle Initial & Last Name & Degree
Nicolas Girard, Professor
Facility Name
Intitut Gustave Roussy
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Besse, Professor
Email
benjamin.besse@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Benjamin Besse, Professor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma

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