Investigation of Mass Balance of the Test Drug and Major Metabolites

Study Overview
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Brief Summary
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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
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The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Official Title
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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

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: Sagopilone (BAY 86-5302, ZK 219477)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sagopilone<br>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. | Drug: Sagopilone (BAY 86-5302, ZK 219477)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Maximum plasma concentration for [14C]-ZK 219477, ZK 219477 | 14 days | 
| tmax | Time to Cmax for [14C]-ZK 219477, ZK 219477 | 14 days | 
| AUC | Area under the concentration time curve for [14C]-ZK 219477, ZK 219477 | 14 days | 
| AUC(0-tlast) | AUC from administration until the last time point with measurable concentration for [14C]-ZK 219477, ZK 219477 | 14 days | 
| AUC(0-24) | AUC from time zero to 24 hours for [14C]-ZK 219477, ZK 219477 | 14 days | 
| MRT | Mean residence time for [14C]-ZK 219477, ZK 219477 | 14 days | 
| t1/2 | Terminal half-life for [14C]-ZK 219477, ZK 219477 | 14 days | 
| λz | Apparent terminal rate constant for [14C]-ZK 219477, ZK 219477 | 14 days | 
| CL | Total clearance for ZK 219477 | 14 days | 
| Vss | Apparent volume of distribution at steady state for ZK 219477 | 14 days | 
| Vz | Apparent volume of distribution during terminal phase for ZK 219477 | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Approximately 12 weeks to 30 weeks | 
| Overall response | Determination of complete response (CR), partial response (PR), unknown, stable disease, progressive disease (PD) by the modified Response Evaluation Criteria in Solid Tumors | Approximately 10 to 32 weeks | 
| Best overall response | Overall response as obtained at all time points available for an individual subject combined to the 'best overall response' | Approximately 10 to 32 weeks | 
| Responders | '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' | Approximately 10 to 32 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Tumor, Malignancy, Mass Balance, Chemotherapy, Drug, Cancer Treatment, Intravenous Infusion, Epothilone, Solid Tumor