Trial Condition(s):

Neoplasms

investigation of mass balance of the test drug and major metabolites

Bayer Identifier:

91490

ClinicalTrials.gov Identifier:

NCT00432302

EudraCT Number:

2006-000188-26

Study Completed

Trial Purpose

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

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 Summary

Enrollment Goal
7
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

CHC Clinique Saint-Joseph

LIEGE, Belgium, 4000

Status
Completed
 

Trial Design