Dose Escalation Study of BI 2536 BS in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit

Exclusion Criteria

• •Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
• •Pregnancy or breastfeeding
• •Active infectious disease
• •Known brain metastases
• •Second malignancy requiring therapy
• •Absolute neutrophil count less than 1500/mm3
• •Platelet count less than 100 000/mm3
• •Bilirubin greater than 1.5 mg/dl (\> 26 μmol/L)
• •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)
• •Serum creatinine greater than 1.5 mg/dl (\> 132 μmol/L)
• •Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
• •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)