advanced thymic epithelial tumour (TET) progressing after primary chemotherapy MedDRA version: 21.1 Level: PT Classification code 10055108 Term: Thymic cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10043670 Term: Thymoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 1004
Conditions
Sponsors
Department of Oncology Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically confirmed advanced TET (thymoma or thymic carcinoma) -Progression after primary chemotherapy -Not more than 2 previous lines (neoadj or chemoradiotherapy will count as 1 line if disease progression has occurred within 6 months. -Inoperable per local Investigator (Masaoka Stage III or IV) -Progression after treatment with least one platinum containing chemotherapy regimen -Measurable disease (RECIST 1.1) -Age =18 years -ECOG PS =9.0mmol/dL -Hepatic function: bilirubin 30 ml/min according to Cockcroft-Gault -Patients of childbearing potential must agree to use adequate birth control during and for 7 months after participation in this study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •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;Secondary Objective: •To determine the efficacy of Selinexor in adults with TETs determined by overall response rate according to modified ITMIG response criteria •To determine the overall response rate of selinexor in patients with advanced thymic carcinoma with squamous cell histology •To determine six months PFS of patients with TET treated with selinexor •To determine overall survival of patients with TET treated with selinexor •To evaluate exploratory biomarkers for prediction of response to selinexor in patients with TET •To determine progression free survival in patients with advanced, inoperable TETs treated with selinexor •To evaluate safety and tolerability of Selinexor;Primary end point(s): Overall response rate according to RECIST 1.1;Timepoint(s) of evaluation of this end point: Assessment of disease status every 8 weeks from start of therapy within study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Overall response rate according to modified ITMIG response criteria 2 Six months PFS 3 Overall survival 4 Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03 ;Timepoint(s) of evaluation of this end point: 1.Assessment of disease status every 8 weeks from start of therapy within study 2 Six months after start of treatment within the study 3 At the time of death of patient 4 From start of therapy within study to End of treatent visit | — |
Countries
Denmark, United States
Contacts
Public ContactPeter Meidahl Petersen
Department of Oncology Rigshospitalet
Outcome results
None listed