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

Stopped early · Phase 2

Conditions studied: Thymoma, Advanced Thymic Epithelial Tumor

In brief

The purpose of this study is to evaluate the safety, tolerability and effectiveness of selinexor in patients with advanced thymic epithelial tumor progressing after primary chemotherapy. This is a multicenter, open label phase II trial that uses a Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with at least one platinum containing chemotherapy regimen. This study is comprised of 2 similar phase II trials, one running in US (25 patients) and one running in EU (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

Key facts

Study ID: NCT03193437
Run by: Georgetown University
People needed: 8
Starts: 2018-04-03
Expected to finish: 2022-01-31
Last updated by the study team: 2023-02-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically confirmed advanced TET (thymoma)
Progression after Primary Chemotherapy
No more than two previous lines (Neoadjuvant or chemoradiotherapy will count as one 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 <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 or five half lives 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; Hemoglobin > 9.0 gm/dL
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 7 months after participation in this study

You may not qualify if…

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
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

Where it is running

Georgetown Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
John Theurer Cancer Center - Hackensack University Medical Center — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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