Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma

Thymoma Clinical Trial

— TET-SEL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03466827
• Other study ID #: TET-SEL
• Status: Recruiting
• Phase: Phase 2
• First received: March 9, 2018
• Last updated: March 9, 2018
• Start date: October 12, 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: March 2018
• Source: Rigshospitalet, Denmark
• Contact: Morten Mau-Soerensen, MD, PhD
• Phone: +45 3545 0879
• Email: paul.morten.mau-soerensen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Description:

Not provided

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Thymic Epithelial Tumour
• Neoplasms, Glandular and Epithelial
• Thymoma
• Thymus Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
France	Hospices Civils de Lyon	Lyon
France	Intitut Curie	Paris
France	Intitut Gustave Roussy	Paris

Sponsors (6)

Lead Sponsor	Collaborator
Morten Mau-Soerensen	GSO Global Clinical Research BV, Gustave Roussy, Cancer Campus, Grand Paris, Hospices Civils de Lyon, Institut Curie, Karyopharm Therapeutics Inc

Countries where clinical trial is conducted

Denmark,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	To determine the overall response rate according to RECIST 1.1	24 months
Secondary	Progression Free Survival	To determine six months progression free survival of patients with TET treated with selinexor	6 months
Secondary	Adverse Events	The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03	24 months