Efficacy of medical treatment with SOM230 LAR in patients with primary inoperable thymoma and/or with local recurrent thymoma to reduce tumor size

Freistaat Bayern, represented by Universität Regensburg0 sitesStarted: November 8, 2010Last updated: February 1, 2016

Overview

No summary available.

•1\.Male or female patients aged \=18 years
•2\.Diagnosis of thymoma as assessed by biopsy and/or szintigraphy
•3\.Inoperability of thymoma or loco\-regional metastases. Inoperability is defined as at least adherence of the tumor to the neighbored organs, suspicious to infiltrate neighbored organs or local metastasis so that R0 resection can not be expected and /or local recurrence of thymic tumor
•4\.Tumor stage: Thymomas of all WHO based histological subtypes (WHO A, AB, B1, B2, B3\) (Rosai, 1999; Travis 2004\) at Masaoka stage II to IVa based on histological examination of resection specimens or core biopsies.
•5\.Patients with and without thymoma associated paraneoplastic syndrome.
•6\.Performance status 0,1, or 2 (ECOG)
•7\.Patients for whom written informed consent to participate in the study has been obtained
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•Patients having received radiolabeled somatostatin analogue therapy within the 6 months or any cytotoxic chemotherapy or interferon therapy within the 2 months prior to recording baseline symptoms
•Patients who have undergone major surgery/surgical therapy for any cause within 1 month or surgical therapy of loco\-regional metastases within the last 3 months before recording baseline symptoms
•Patients who have received radiotherapy for any reason within the last 4 weeks and must have recovered from any side effects of radiotherapy before recording baseline symptoms
•Patients who are not biochemically euthyroid
•Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as indicated by HbA1C \> 8%
•Patients with symptomatic cholelithiasis
•Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
•Patients with QT related risk factors:
•\-QTcF at screening \> 450 msec
•\-History of syncope or family history of idiopathic sudden death

Sponsor

Freistaat Bayern, represented by Universität Regensburg