Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma (TET-SEL)
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ClinicalTrials.gov Identifier: NCT03466827 |
Recruitment Status : Unknown
Verified March 2018 by Morten Mau-Soerensen, Rigshospitalet, Denmark.
Recruitment status was: Recruiting
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
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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 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
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 |

- 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
- Overall Response Rate [ Time Frame: 24 months ]To determine the overall response rate according to RECIST 1.1
- Progression Free Survival [ Time Frame: 6 months ]To determine six months progression free survival of patients with TET treated with selinexor
- Adverse Events [ Time Frame: 24 months ]The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

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
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 |
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 |
Study Director: | Morten Mau-Soerensen, MD, PhD | Rigshospitalet, Denmark |
Responsible Party: | Morten Mau-Soerensen, Chief Physician, MD, PhD, Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT03466827 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Thymoma Thymus Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Complex and Mixed Neoplasms by Histologic Type |
Neoplasms Thoracic Neoplasms Neoplasms by Site Lymphatic Diseases |