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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014