Dose Finding Study of BI 6727 (Volasertib) in Patients With Various Solid Cancers

A Phase I Single Dose Escalation Study of Two Dosing Schedules of BI 6727 Administered Intravenously in Asian Patients With Various Solid Cancers With Repeated Administration in Patients With Clinical Benefit

The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 in Asian cancer patients, and to provide safety data in terms of drug-related adverse events.

Inclusion criteria:

1. Patients with histologically or cytologically confirmed diagnosis of advanced solid cancer
2. Age 18 years or older
3. Written informed consent
4. Eastern Cooperative Oncology Group (ECOG) performance score 2 or less

Exclusion criteria:

1. Serious illness or concomitant non-oncological disease.
2. Pregnancy or breast feeding
3. Active infectious disease
4. Absolute neutrophil count less than 1,500/cubic millimeter
5. Platelet count less than 100,000/cubic millimeter
6. Bilirubin greater than 1.5 mg/dL (> 26 µmol/L, SI unit equivalent)
7. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal
8. Serum creatinine greater than 1.5x ULN.