Sorafenib (NEXAVAR) Monotherapy in Patients With Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy
1. Male patients > 18 years of age
2. Patients with histologically proven germ cell neoplasm (gonadal or extragonadal
3. Patients must have the disease not amendable to cure with either surgery or
4. Patients must have failed at least two cisplatin-based combination chemotherapy
5. Failure on prior regimens will be defined as either:
- A ≥ 25% increase in sum of target lesions, new lesions, or
- An increasing AFP or HCG above the nadir level.
6. Patients with at least one measurable lesion by CT scan or MRI according to RECIST
7. Adequate bone marrow, liver and renal function, assessed no longer than 14 days
before treatment start, defined by the following laboratory test limits: WBC > 2.0 x
109/l and platelets > 60 x 109/l, total bilirubin < 2 x upper limit, AST and ALT < 5
x upper limit normal, serum creatinine < 2 x UNL
8. WHO Performance Status 0, 1, 2
9. No concurrent chemotherapy or radiotherapy
10. Life expectancy of at least 12 weeks
11. Absence of any physiological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule
12. A signed informed consent must be obtained prior to any study specific procedures
13. All patients must agree to use adequate contraception during the whole study period
1. Patients not fulfilling of inclusion criteria
2. Primary radiotherapy in the field of target lesion
3. Major surgery (RPLND) within 4 weeks before the start of study drug or concurrent
serious non-healing wounds, ulcers or bone fractures.
4. Known serious and active bacterial, viral or fungal infection (> grade II CTC-AE)
including HBV, HCV and HIV carrier state.
5. Previous or concurrent malignancy except for basal cell carcinoma of the skin
6. Uncontrolled hypertension.
7. Thrombotic or embolic event in last 6 months prior to inclusion.
8. Impairment of gastrointestinal tract, or GI disease that may influence the
bioavailability of oral sorafenib
9. Substance and alcohol abuse (nicotine use is allowed)
10. Known or suspected hypersensitivity to sorafenib.
11. Participants in any other clinical trial using investigational drug within 4 weeks
prior to study entry
12. Prior use of investigational or licensed angiogenesis and RAF kinase or MEK
13. Patient unwilling or unable to give informed consent
14. Any condition that may in the investigator's opinion jeopardize the
safety of the patient or his compliance in the study.