germ cell tumor
Conditions
Interventions
Trade Name: Sutent
Product Name: Sutent
Product Code: 35917, 35916, 35915
Pharmaceutical Form: Capsule*
Sponsors
Narodny onkologicky ustav
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients older than 18 years,2. Radiological and/or serological proof of relapsed metastatic germ cell tumor,3. Patient’s disease must not be amenable to cure with either surgery or chemotherapy in the opinion of investigator, 4. Patients have to fail at least two platinum-based regimens or one platinum based regimen in case of platinum-refractory disease or primary mediastinal non-seminomatous germ cell tumor, 5. ECOG performance status: 0-2,6. No previous malignancy, except for basal-cell carcinoma of the skin,7. Adequate organ function: total serum bilirubin 8g/dl,9. Controlled hypertension,10. At least 4 weeks must have elapsed since the last surgery, radiotherapy and/or chemotherapy before study entry, 11. Complete recovery from prior surgery, and/or reduction of all adverse events from previous systemic therapy or radiotherapy to grade 1, 12. No concurrent treatment with experimental drugs,13. No concurrent chemotherapy,14. No concurrent radiotherapy,15. Measurable disease radiologically and/or according to serum tumor markers,16. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule,17. Signed informed consent 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who do not fit inclusion criteria,2. Female patients,3. Patients infected by the Human Immunodeficiency Virus (HIV),4. Patients with congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina or any unstable arrhytmia requiring medication,5. Patients with other sever acute or chronic medical condition, or laboratory abnormality that would impair, in the judgment of investigator, excess risk associated with study treatment, or which, in judgment of the investigator, would make the patient inappropriate for entry into this study,6. Inability of oral intake, or drug absorbtion (e.g. malabsorption syndrome),7. Hypersensitivity to any compound of the drug,8. Sexually active men not using effective birth control if their partners are women of child-bearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 12-month post treatment initiation continuous progression-free survival;Secondary Objective: Overall response, duration of response, overall survival, toxicity;Primary end point(s): Twelve-month post treatment initiation continuous progression-free survival rate (intent-to-treat population) | — |
Countries
Slovakia
Outcome results
None listed