Selinexor in patients with advanced thymoma and thymic carcinoma

Phase 1

• Conditions: advanced thymic epithelial tumour (TET) progressing after primary chemotherapy; MedDRA version: 21.1Level: PTClassification code 10055108Term: Thymic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10043670Term: ThymomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10043674Term: Thymoma malignant recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10061031Term: Thymoma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002612-40-DK
• Lead Sponsor: Department of Oncology Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-26
• Last Update Posted: 24 April 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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 <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 5 half lifes interval from any investigational agents or cytotoxic chemotherapy to start of study is required (whichever is shorter)
-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, circulating lymphocytes < 50,000/mm³, Haemoglobin >=9.0mmol/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
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

•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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified