Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy

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 chemotherapy regimen

- 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