Investigation of Mass Balance of the Test Drug and Major Metabolites

Bayer

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: Sagopilone (BAY 86-5302, ZK 219477)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00432302

2006-000188-26 (EudraCT Number)

310301 (Other Identifier)

91490

Details and patient eligibility

About

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

Full description

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

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Sagopilone

Experimental group

Description:

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.

Treatment:

Drug: Sagopilone (BAY 86-5302, ZK 219477)