BI 6727 (Volasertib) Human ADME Trial in Various Solid Tumours
Condition: Neoplasms
Intervention: BI 6727
Intervention description: PLK-1 inhibitor
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Male
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Investigation of absorption, distribution, metabolism and excretion (ADME) and assessment of
      safety, tolerability and preliminary therapeutic effects of [14C]volasertib in patients with
      advanced solid tumours.
    

Eligibility criteria:

        Inclusion criteria:

          -  Inclusion Criteria 1. Patients with histologically or cytologically confirmed
             diagnosis of advanced, non resectable and / or metastatic solid tumour

          -  Inclusion Criteria 2. Male

          -  Inclusion Criteria 3. Age >=18 and =<70 years

          -  Inclusion Criteria 4. Written informed consent

          -  Inclusion Criteria 5. Eastern Cooperative Oncology Group (ECOG) performance score =<2

          -  Inclusion Criteria 6. Recovery from Common Terminology Criteria for Adverse Events
             (CTCAE) Grade >=2 therapy-related toxicities from previous chemo-, hormone-, immuno-,
             or radiotherapy

        Exclusion criteria:

          -  Exclusion Criteria 1. Serious concomitant non-oncological disease considered by the
             investigator

          -  Exclusion Criteria 2. Active infectious disease

          -  Exclusion Criteria 3. Viral hepatitis, Human Immunodeficiency Virus (HIV) infection

          -  Exclusion Criteria 4. Clinical evidence of active brain metastasis during the past 6
             months

          -  Exclusion Criteria 5. Second malignancy currently requiring active therapy

          -  Exclusion Criteria 6. Absolute neutrophil count less than 1,500/mm3

          -  Exclusion Criteria 7. Platelet count less than 100,000/mm3

          -  Exclusion Criteria 8. Total bilirubin greater than 1.5 mg/dL

          -  Exclusion Criteria 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)

          -  Exclusion Criteria 10. Serum creatinine greater than 1.5x Upper Limit of Normal (ULN).

          -  Exclusion Criteria 11. Known history of QT/QTcF-prolongation

          -  Exclusion Criteria 12. Patients who are sexually active and having a partner with
             childbearing potential and unwilling to use a medically acceptable method of
             contraception

          -  Exclusion Criteria 13. Treatment with other investigational drugs or participation in
             another clinical trial

          -  Exclusion Criteria 14. Chemo-, radio- immuno-, or molecular-targeted cancer-therapy
             within the past four weeks prior to start of therapy or concomitantly with this trial.
             This restriction does not apply to steroids and bisphosphonates.

          -  Exclusion Criteria 15. Alcohol abuse

          -  Exclusion Criteria 16. Life expectancy less than 12 weeks

          -  Exclusion Criteria 17. Potent Cytochrome P450 enzyme (CYP) 3A4 and P-glycoprotein
             inhibitors or inducers

          -  Exclusion Criteria 18. History of allergy/hypersensitivity