Investigation of Mass Balance of the Test Drug and Major Metabolites
- Registration Number
- NCT00432302
- Lead Sponsor
- Bayer
- Brief Summary
The purpose of this study is to: a) Determine how the body takes up the test drug and distributes it into various body organs and tissues, how it processes the drug and how it ultimately removes it; and b) Examine how well the test drug works against cancer, and whether it is safe and tolerable to take
- Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- Male ≥ 18 years; female ≥ 50 years without childbearing potential (confirmed by either: age ≥ 60; or history of hysterectomy; or hormone analysis in serum: Estradiol ≤ 20 pg/mL and follicle stimulating hormone ≥ 40 IU/L)
- Solid tumor
- Adequate function of major organs
- Failed previous cancer treatment
- Peripheral venous access
- Concurrent severe and/or uncontrolled disease
- Brain tumors
- Marked constipation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sagopilone Sagopilone (BAY 86-5302, ZK 219477) Subjects received 28 mg ZK 219477, containing 14 kBq/7.8 µg \[14C\]-ZK 219477 in the first infusion (Treatment course 1) followed by subsequent infusions (Treatment courses 2 to n \[till disease progression\]) of 16 mg/m2 ZK 219477 without radioactive label. Interval between the treatments was at least 21 days.
- Primary Outcome Measures
Name Time Method 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. 14 days Cmax 14 days Maximum plasma concentration for \[14C\]-ZK 219477, ZK 219477
tmax 14 days Time to Cmax for \[14C\]-ZK 219477, ZK 219477
AUC 14 days Area under the concentration time curve for \[14C\]-ZK 219477, ZK 219477
AUC(0-tlast) 14 days AUC from administration until the last time point with measurable concentration for \[14C\]-ZK 219477, ZK 219477
AUC(0-24) 14 days AUC from time zero to 24 hours for \[14C\]-ZK 219477, ZK 219477
MRT 14 days Mean residence time for \[14C\]-ZK 219477, ZK 219477
t1/2 14 days Terminal half-life for \[14C\]-ZK 219477, ZK 219477
λz 14 days Apparent terminal rate constant for \[14C\]-ZK 219477, ZK 219477
CL 14 days Total clearance for ZK 219477
Vss 14 days Apparent volume of distribution at steady state for ZK 219477
Vz 14 days Apparent volume of distribution during terminal phase for ZK 219477
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events Approximately 12 weeks to 30 weeks Overall response Approximately 10 to 32 weeks Determination of complete response (CR), partial response (PR), unknown, stable disease, progressive disease (PD) by the modified Response Evaluation Criteria in Solid Tumors
Best overall response Approximately 10 to 32 weeks Overall response as obtained at all time points available for an individual subject combined to the 'best overall response'
Responders Approximately 10 to 32 weeks 'Response' was considered to be established if 'Best overall response' of PR or CR was confirmed at any time after the start of study treatment. If response was established, a subject was referred to as a 'responder'