Neoplasms
Conditions
Keywords
Cancer, Tumor, Malignancy, Mass Balance, Chemotherapy, Drug, Cancer Treatment, Intravenous Infusion, Epothilone, Solid Tumor
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.
Interventions
DRUGSagopilone (BAY 86-5302, ZK 219477)
First infusion only: 28 mg, containing 14 kBq/7.8 mcg \[14C\]-ZK 219477. Subsequent infusions: 16 mg/m2 ZK 219477 without radioactive label. IV infusion was given over a period of 30 min.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Concurrent severe and/or uncontrolled disease * Brain tumors * Marked constipation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vz | 14 days | Apparent volume of distribution during terminal phase for 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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' |
| Number of participants with adverse events | Approximately 12 weeks to 30 weeks | — |
Countries
Belgium
Outcome results
None listed