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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: BI 6727

Study type: Interventional

Funder types: Industry

Identifiers

NCT01145885

2009-018199-32 (EudraCT Number)

1230.23

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

BI 6727

Experimental group

Description:

BI 6727 cycles in every 21 days

Treatment:

Drug: BI 6727