Inclusion Criteria
Inclusion criteria:
- Inclusion Criteria 1. Patients with histologically or cytologically confirmed
diagnosis of advanced, non resectable and / or metastatic solid tumour
- Inclusion Criteria 2. Male
- Inclusion Criteria 3. Age >=18 and =<70 years
- Inclusion Criteria 4. Written informed consent
- Inclusion Criteria 5. Eastern Cooperative Oncology Group (ECOG) performance score =<2
- Inclusion Criteria 6. Recovery from Common Terminology Criteria for Adverse Events
(CTCAE) Grade >=2 therapy-related toxicities from previous chemo-, hormone-, immuno-,
or radiotherapy
Exclusion criteria:
- Exclusion Criteria 1. Serious concomitant non-oncological disease considered by the
investigator
- Exclusion Criteria 2. Active infectious disease
- Exclusion Criteria 3. Viral hepatitis, Human Immunodeficiency Virus (HIV) infection
- Exclusion Criteria 4. Clinical evidence of active brain metastasis during the past 6
months
- Exclusion Criteria 5. Second malignancy currently requiring active therapy
- Exclusion Criteria 6. Absolute neutrophil count less than 1,500/mm3
- Exclusion Criteria 7. Platelet count less than 100,000/mm3
- Exclusion Criteria 8. Total bilirubin greater than 1.5 mg/dL
- Exclusion Criteria 9. Aspartate amino transferase (AST) and / or alanine amino
transferase (ALT) greater than 2.5 times the upper limit of normal (if related to
liver metastases greater than five times the upper limit of normal)
- Exclusion Criteria 10. Serum creatinine greater than 1.5x Upper Limit of Normal
(ULN).
- Exclusion Criteria 11. Known history of QT/QTcF-prolongation
- Exclusion Criteria 12. Patients who are sexually active and having a partner with
childbearing potential and unwilling to use a medically acceptable method of
contraception
- Exclusion Criteria 13. Treatment with other investigational drugs or participation in
another clinical trial
- Exclusion Criteria 14. Chemo-, radio- immuno-, or molecular-targeted cancer-therapy
within the past four weeks prior to start of therapy or concomitantly with this
trial. This restriction does not apply to steroids and bisphosphonates.
- Exclusion Criteria 15. Alcohol abuse
- Exclusion Criteria 16. Life expectancy less than 12 weeks
- Exclusion Criteria 17. Potent Cytochrome P450 enzyme (CYP) 3A4 and P-glycoprotein
inhibitors or inducers
- Exclusion Criteria 18. History of allergy/hypersensitivity