Phase II study of sunitinib malate (SUTENT®) in relapsed germ cell tumors in males.

Phase 1

• Conditions: germ cell tumor

• Registration Number: EUCTR2007-004981-42-SK
• Lead Sponsor: arodny onkologicky ustav

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-15
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 28

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 <2xULN (exemption are patients with Gilbert disease), serum transaminases <5xULN, serum creatinine <2xULN, serum lipase within normal limits8. Absolute granulocyte count ³ 1,000/mm3, platelets ³ 75,000 mm3, hemoglobin >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

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.

Study & Design

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