Status:
COMPLETED
BI 6727 (Volasertib) Human ADME Trial in Various Solid Tumours
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Neoplasms
Eligibility:
MALE
18-70 years
Phase:
PHASE1
Brief 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 sol...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01145885
Start Date
June 1 2010
End Date
November 1 2010
Last Update
January 31 2019
Active Locations (1)
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1
1230.23.36001 Boehringer Ingelheim Investigational Site
Budapest, Hungary