Clinical trial · Interventional
BI 6727 (Volasertib) Human ADME Trial in Various Solid Tumours
Investigation of the Metabolism, Excretion and Pharmacokinetics of an Openlabel Single Dose of 300 mg [14C]Volasertib Administered Intravenously in Patients With Various Solid Tumours With a Possible Extension Phase With Nonlabelled Drug
NCT01145885CI-TRIAL-00036862completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BI 6727 | Drug | Volasertib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BI 6727
- description
- BI 6727 cycles in every 21 days
- interventionNames
- Drug: BI 6727
Primary outcomes (16)
- measure
- Individual Time Course Profiles of 14C-radioactivity in Whole Blood and Plasma: Cmax of 14C Labelled Volasertib
- timeFrame
- Whole blood: Pre-dose (-0.5 hours (h)) and 1.0h, 1.983h, 4h, 6h, 8h and 24h after start of the 2h drug infusion.Plasma: Pre-dose (-0.5h) and 1.0h, 1.983h, 4h, 6h, 8h, 24h,48h. 96h, 168h and 336h after start of drug infusion.
- description
- Individual time course profiles of 14C-radioactivity in whole blood and plasma: Cmax of 14C labelled Volasertib.
- measure
- Individual Time Course Profiles of 14C-radioactivity in Urine: Cumulative Fraction of 14C-ratioactivity Excreted in Urine
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.