Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT00772694
Eligibility Criteria:
Inclusion Criteria:
1. Male patients \> 18 years of age
2. Patients with histologically proven germ cell neoplasm (gonadal or extragonadal primary)
3. Patients must have the disease not amendable to cure with either surgery or chemotherapy
4. Patients must have failed at least two cisplatin-based combination chemotherapy regimens.
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 criteria
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
Exclusion Criteria:
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 inhibitors.
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00772694
Study Brief:
Protocol Section:
NCT00772694