BI 6727 (Volasertib) Human ADME Trial in Various Solid Tumours

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01145885
First received: June 16, 2010
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


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: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01145885     History of Changes
Other Study ID Numbers: 1230.23, 2009-018199-32
Study First Received: June 16, 2010
Last Updated: October 31, 2013
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014