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BI 6727 Human ADME Trial in Various Solid Tumours

Phase 1
18 Years
70 Years
Not Enrolling

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Trial Information

BI 6727 Human ADME Trial in Various Solid Tumours

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

- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Individual time course profiles of 14C-radioactivity in nmol/L in whole blood, plasma and urine and in nmol/kg for faeces

Outcome Time Frame:

3 weeks

Safety Issue:


Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals


Hungary: National Institute of Pharmacy

Study ID:




Start Date:

June 2010

Completion Date:

Related Keywords:

  • Neoplasms
  • Neoplasms