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

NCT ID: NCT01145885

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2010-11-30

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.

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BI 6727

BI 6727 cycles in every 21 days

Group Type: EXPERIMENTAL

BI 6727

Intervention Type: DRUG

PLK-1 inhibitor

Interventions

BI 6727

PLK-1 inhibitor

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1230.23.36001 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Countries

Hungary

Other Identifiers

2009-018199-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1230.23

Identifier Type: -

Identifier Source: org_study_id