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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01145885
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : November 1, 2013
Information provided by (Responsible Party):
Boehringer Ingelheim

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 solid tumours.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: BI 6727 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2010
Actual Primary Completion Date : November 2010

Arm Intervention/treatment
Experimental: BI 6727
BI 6727 cycles in every 21 days
Drug: BI 6727
PLK-1 inhibitor

Primary Outcome Measures :
  1. 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 ]
  2. Individual time course profiles of BI 6727 and its metabolite CD 10899 in plasma and urine [ Time Frame: 3 weeks ]
  3. 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 ]
  4. Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces [ Time Frame: 3 weeks ]
  5. Time dependency (if feasible) of Cblood cells/Cplasma ratio and Cblood/Cplasma ratio of 14C-radioactivity [ Time Frame: 3 weeks ]
  6. 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 ]

Secondary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety [ Time Frame: 52 weeks ]
  2. Tolerability of BI 6727 [ Time Frame: 52 weeks ]
  3. Assessment of preliminary therapeutic effects of BI 6727 [ Time Frame: 52 weeks ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01145885

1230.23.36001 Boehringer Ingelheim Investigational Site
Budapest, Hungary
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim Identifier: NCT01145885     History of Changes
Other Study ID Numbers: 1230.23
2009-018199-32 ( EudraCT Number: EudraCT )
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013