Primary inoperable thymoma and/or local recurrent thymoma MedDRA version: 14.1 Level: PT Classification code 10043670 Term: Thymoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Pasireotide LAR
Product Code: SOM230 LAR
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Pasireotide LAR
Current Sponsor code: SOM230 LAR
Concen
Sponsors
Freistaat Bayern, represented by Universität Regensburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 F.1.2.1 Number of subjects for this age range 13 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: • 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 - Sudden or clinically significant cardiac arrhythmias - Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant / symptomatic bradycardia, or high-grade AV block - Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes or Parkinson’s disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure - Concomitant medication(s) known to increase the QT interval • Patients with potassium 1.5 X ULN, serum albumin < 0.67 X LLN, and/or ALT or AST more than 2 X ULN for patients without liver metastases or ALT or AST more than 5X ULN for patients with documented liver metastases • Patients with additional active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix) • Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed • Patients with abnormal coagulation (PT or APTT elevated by 30% above normal limits) • Patients with WBC <2.5 X 109/L; Hgb <10 g/dL; PLT <100 X 109/L (patients with paraneoplastic pan-, leuco-, erythro- or thrombopenia can be included if this seems to be the only reason for pan-, leuco-, erythro- or thrombopenia) • Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR or s.c. formulations • Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator • Female patients who are pregnant or lactating, or are of childbe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Tumor shrinkage Response is defined as the decrease in tumor volume of 20 % at EOS as compared to baseline. ;Secondary Objective: • Resection status The frequency distribution of the resection status will be presented based on the categories R0, R1 and ? R2 • Evaluation of histological and flow cytometric changes under treatment with SOM230 LAR. 1) percentage of necrotic area 2) degree of depletion (none, slight; moderate; marked) of immature T-cells (immunohistochemistry for CD1a, CD99, CD3 expression 3) change of T-cell subset composition as revealed by FACS analysis (Ströbel et al. BLOOD, 2002). • Safety The assessment of safety will be based mainly on the frequency of Adverse Events and on the number of laboratory values that fall outside of pre-determined ranges. ;Primary end point(s): Tumor shrinkage Response is defined as the decrease in tumor volume of 20 % at EOS as compared to baseline. ;Timepoint(s) of evaluation of this end point: EOS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Resection status The frequency distribution of the resection status will be presented based on the categories R0, R1 and >= R2. Evaluation of histological and flow cytometric changes under treatment with SOM230 LAR. 1) percentage of necrotic area 2) degree of depletion (none, slight; moderate; marked) of immature T-cells (immunohistochemistry for CD1a, CD99, CD3 expression 3) change of T-cell subset composition as revealed by FACS analysis (Ströbel et al. BLOOD, 2002). ;Timepoint(s) of evaluation of this end point: EOS | — |
Countries
Germany
Contacts
Public ContactProject Manager
CROLLL GmbH
Outcome results
None listed