Intravenous BI 6727 (Volasertib) in 2nd Line Treatment of Urothelial Cancer

Exclusion Criteria

• •1. More than one prior regimen of chemotherapy including prior adjuvant therapy
• •2. Brain metastases
• •3. Patients with bone metastasis as the only site of disease are excluded
• •4. Serious illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety, interfere with the evaluation of the safety of the test drug or limit compliance with trial requirements.
• •5. QTc prolongation deemed clinically relevant by the investigator
• •6. Second malignancy currently requiring active therapy
• •7. Other active malignancy diagnosed within the past 3 years (other than non melanomatous skin cancer and cervical intraepithelial neoplasia)
• •8. Absolute neutrophil count (ANC) \<1,500/µl
• •9. Platelet count \<100,000/µl
• •10. Hemoglobin \<9 g/dl
• •11. Total bilirubin \>1.5 mg/dl
• •12. Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) \>2.5 x ULN, or aspartate amino transferase (AST) and/or alanine amino transferase (ALT) \>5 x ULN in case of known liver metastases
• •13. Serum creatinine \>1.5 x ULN
• •14. Chemo-, Radio- or immunotherapy within the past 4 weeks. This does not apply to steroids and bisphosphonates.
• •15. Active infectious disease, or HIV, Hepatitis-B or -C infection
• •16. Active drug or alcohol abuse
• •17. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial
• •18. Pregnancy or breast feeding
• •19. Treatment with any investigational drug within the past 4 weeks or within less than four half-life times of the investigational drug before treatment with the trial drug and/or persistence of toxicities of prior anticancer therapies which are deemed to be clinically relevant.
• •20. Prior treatment with Polo-like kinase 1 (Plk1) inhibitor
• •21. Patient unable to comply with the protocol
• •22. Any known hypersensitivity to the trial drugs or their excipients