NCT00818623

Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients

An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. Thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect.

Detailed description

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Degarelix	Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection
DRUG	Degarelix	Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection
DRUG	Degarelix	Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection
DRUG	Degarelix	Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection
DRUG	Degarelix	Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection
DRUG	Degarelix	Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection
DRUG	Degarelix	Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection
DRUG	Degarelix	Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection

Timeline

• Start date: 2002-11-01
• Primary completion: 2004-10-01
• Completion: 2004-10-01
• First posted: 2009-01-08
• Last updated: 2023-11-30
• Results posted: 2009-03-31

Locations

30 sites across 7 countries: Denmark, Finland, Hungary, Norway, Romania, Russia, Sweden