Investigation of Mass Balance of the Test Drug and Major Metabolites

Bayer7 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms

Interventions

Sagopilone (BAY 86-5302, ZK 219477)DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Liège, Belgium

Outcomes

Primary Outcomes

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.

Time frame: 14 days

Cmax

Maximum plasma concentration for \[14C\]-ZK 219477, ZK 219477

Time frame: 14 days

tmax

Time to Cmax for \[14C\]-ZK 219477, ZK 219477

Time frame: 14 days

AUC

Area under the concentration time curve for \[14C\]-ZK 219477, ZK 219477

Time frame: 14 days

AUC(0-tlast)

AUC from administration until the last time point with measurable concentration for \[14C\]-ZK 219477, ZK 219477

Time frame: 14 days

AUC(0-24)

AUC from time zero to 24 hours for \[14C\]-ZK 219477, ZK 219477

Time frame: 14 days

MRT

Mean residence time for \[14C\]-ZK 219477, ZK 219477

Time frame: 14 days

t1/2

Terminal half-life for \[14C\]-ZK 219477, ZK 219477

Time frame: 14 days

λz

Apparent terminal rate constant for \[14C\]-ZK 219477, ZK 219477

Time frame: 14 days

Data from ClinicalTrials.gov

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Secondary Outcomes

Number of participants with adverse events

Time frame: 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

Time frame: 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'

Time frame: 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'

Time frame: Approximately 10 to 32 weeks