BI 6727 (Volasertib) Human ADME Trial in Various Solid Tumours
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01145885
First received: June 16, 2010
Last updated: February 8, 2012
Last verified: February 2012
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Purpose
This open label phase I trial 1230.23 will investigate the pharmacokinetics (absorption, distribution, metabolism and excretion (ADME)) of the specific Polo-like kinase 1(PLK-1) inhibitor BI 6727 in tumour patients. Major tasks involve the structure elucidation of metabolites as well as the 14C-radioactivity in blood cells, plasma, urine and faeces. This study will also help in determining the metabolic pathways following intravenous administration of [14C]-radiolabelled BI 6727. Determination of human ADME is the primary endpoint of this trial. Human ADME will be evaluated in patients during the first BI 6727 treatment cycle only. If clinical benefit from BI 6727 treatment is indicated, patients may receive additional cycles of BI 6727. ADME will not be investigated in further cycles. Secondary endpoints of this trial are safety, tolerability and the assessment of preliminary therapeutic effects of BI 6727.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: BI 6727 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | BI 6727 Human ADME Trial in Various Solid Tumours |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Individual time course profiles of 14C-radioactivity in nmol/L in whole blood, plasma and urine and in nmol/kg for faeces [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Individual time course profiles of BI 6727 and its metabolite CD 10899 in plasma and urine [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Estimation of pharmacokinetic parameters using non-compartmental methods: from plasma and urinary concentrations of BI 6727 and its metabolite CD 10899; from whole blood, plasma, urinary and faecal concentrations of the 14C-radioactivity [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Time dependency (if feasible) of Cblood cells/Cplasma ratio and Cblood/Cplasma ratio of 14C-radioactivity [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Elucidation of metabolite structures and identification of major metabolites in plasma, urine, and faeces (if feasible) in comparison with various animal species (will be reported separately) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of participants with adverse events as a measure of safety [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- Tolerability of BI 6727 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Assessment of preliminary therapeutic effects of BI 6727 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 7 |
| Study Start Date: | June 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BI 6727
BI 6727 cycles in every 21 days
|
Drug: BI 6727
PLK-1 inhibitor
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145885
Locations
| Hungary | |
| 1230.23.36001 Boehringer Ingelheim Investigational Site | |
| Budapest, Hungary | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01145885 History of Changes |
| Other Study ID Numbers: | 1230.23, 2009-018199-32 |
| Study First Received: | June 16, 2010 |
| Last Updated: | February 8, 2012 |
| Health Authority: | Hungary: National Institute of Pharmacy |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013