Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma

Recruitment & 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

Study & Design

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	24 months	To determine the overall response rate according to RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	6 months	To determine six months progression free survival of patients with TET treated with selinexor
Adverse Events	24 months	The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03

Recruitment & Eligibility