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Investigation of Mass Balance of the Test Drug and Major Metabolites

NCT ID: NCT00432302

Last Updated: 2015-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-11-30

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.

Conditions

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Neoplasms

Keywords

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Cancer Tumor Malignancy Mass Balance Chemotherapy Drug Cancer Treatment Intravenous Infusion Epothilone Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sagopilone

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.

Group Type EXPERIMENTAL

Sagopilone (BAY 86-5302, ZK 219477)

Intervention Type 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.

Interventions

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Sagopilone (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.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Liège, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Other Identifiers

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2006-000188-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

310301

Identifier Type: OTHER

Identifier Source: secondary_id

91490

Identifier Type: -

Identifier Source: org_study_id