BI 6727 Administered Intravenously Every 3 Weeks in Patients With Solid Tumours

Exclusion Criteria

• •1. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
• •2. Pregnancy or breastfeeding
• •3. Active infectious disease or known chronic Hepatitis B/Hepatitis C infection
• •4. Clinical evidence of active brain or leptomeningeal disease during the past 12 months
• •5. Second malignancy currently requiring active therapy
• •6. Absolute neutrophil count less than 1500 / mm3
• •7. Platelet count less than 100 000 / mm3
• •8. Bilirubin greater than 1.5 mg / dl (\> 26 ¿mol / L, SI unit equivalent)
• •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)
• •10. Serum creatinine greater than 1.5 mg / dl (\> 132 ¿mol / L, SI unit equivalent)
• •11. Known history of relevant QT-prolongation, e.g. long QT-syndrome
• •12. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
• •13. Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
• •14. Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
• •15. Patients unable to comply with the protocol
• •16. Active alcohol or drug abuse