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

Inclusion criteria:

* Patients with confirmed diagnosis of advanced, non resectable and/or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
* Evaluable tumour deposits
* Age 18 years or older
* Life expectancy of at least six months
* Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation
* Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
* Full recovery from all therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies

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)