A Long Term Safety Study of Degarelix in Patients With Prostate Cancer - Full Text View

Purpose

Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.

Condition	Intervention	Phase
Prostate Cancer	Drug: Degarelix	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Urine and Urination

Drug Information available for: Degarelix

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables [ Time Frame: Up to 22.5 months ] [ Designated as safety issue: Yes ]
The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [ Time Frame: Up to 22.5 months ] [ Designated as safety issue: Yes ]
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.

Other Outcome Measures:

Serum Levels of Prostate Specific Antigen (PSA)Over Time [ Time Frame: from baseline to 72 weeks ] [ Designated as safety issue: No ]
PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)
Serum Levels of Testosterone Over Time [ Time Frame: from baseline to week 72 ] [ Designated as safety issue: No ]
Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)

Enrollment:	77
Study Start Date:	August 2009
Study Completion Date:	December 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Degarelix The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.	Drug: Degarelix

Arms

Assigned Interventions

Experimental: Degarelix

The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.

Drug: Degarelix

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31

Exclusion Criteria:

Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967018

Show 62 Study Locations

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00967018 History of Changes
Other Study ID Numbers:	FE200486 CS34, EudraCT No: 2008-006827-29
Study First Received:	August 18, 2009
Results First Received:	November 23, 2012
Last Updated:	January 2, 2013
Health Authority:	Sweden: Medical Products Agency Finland: Finnish Medicines Agency Norway: Norwegian Medicines Agency Portugal: National Pharmacy and Medicines Institute Italy: The Italian Medicines Agency Belgium: Federal Agency for Medicinal Products and Health Products Turkey: Ministry of Health Spain: Spanish Agency of Medicines France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Greece: National Organization of Medicines

Keywords provided by Ferring Pharmaceuticals:

Safety parameters
ECG, blood and urine samples
general health state

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013