Investigation of Mass Balance and Major Metabolites After Administration of 28 mg Radiolabeled ZK 219477 in Patients With Solid Tumor in an Open-label, Non Randomized Design
18 Years
N/A
Both
Tumors
Trial Information
Investigation of Mass Balance and Major Metabolites After Administration of 28 mg Radiolabeled ZK 219477 in Patients With Solid Tumor in an Open-label, Non Randomized Design
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
renamed to Bayer Schering Pharma AG, Germany.
Inclusion Criteria:
- Solid tumor
- Adequate function of major organs
- Failed previous cancer treatment
- Peripheral venous access
Exclusion Criteria:
- Concurrent severe and/or uncontrolled disease
- Brain tumors
- Marked constipation
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Blood, urine and fecal samples will be collected over a period of 336 hours (14 days) to measure 14C, ZK 219477 and its major metabolites following the intravenous administration of 14C-ZK 219477.
Outcome Time Frame:
14 days
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study ID:
91490
NCT ID:
NCT00432302
Start Date:
January 2007
Completion Date:
November 2007
Related Keywords:
- Tumors
- Cancer
- Tumor
- Malignancy
- Mass Balance
- Chemotherapy
- Drug
- Cancer Treatment
- Intravenous Infusion
- Epothilone
- Solid Tumor
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