E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
12-month post treatment initiation continuous progression-free survival |
|
E.2.2 | Secondary objectives of the trial |
Overall response, duration of response, overall survival, toxicity |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Twelve-month post treatment initiation continuous progression-free survival rate (intent-to-treat population) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
12 months after last patient will terminate treatment |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 60 |
E.8.9.1 | In the Member State concerned days | |