Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

This study has been terminated.
(The doses were not effective in maintaining testosterone suppression)
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00215657
First received: September 20, 2005
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Liver Function Tests [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.

  • Participants With Markedly Abnormal Change in Vital Signs and Body Weight [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.


Enrollment: 131
Study Start Date: March 2003
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Degarelix 120 mg (20 mg/mL)
Degarelix 120 mg (20 mg/mL)
Drug: Degarelix
Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Name: FE200486
Experimental: Degarelix 120 mg (40 mg/mL)
Degarelix 120 mg (40 mg/mL)
Drug: Degarelix
Degarelix 120 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Name: FE200486
Experimental: Degarelix 160 mg (40 mg/mL)
Degarelix 160 mg (40 mg/mL)
Drug: Degarelix
Degarelix 160 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Name: FE200486
Experimental: Degarelix 200 mg (40 mg/mL)
Degarelix 200 mg (40 mg/mL)
Drug: Degarelix
Degarelix 200 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Name: FE200486
Experimental: Degarelix 200 mg (60 mg/mL)
Degarelix 200 mg (60 mg/mL)
Drug: Degarelix
Degarelix 200 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Name: FE200486
Experimental: Degarelix 240 mg (40 mg/mL)
Degarelix 240 mg (40 mg/mL)
Drug: Degarelix
Degarelix 240 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Name: FE200486
Experimental: Degarelix 240 mg (60 mg/mL)
Degarelix 240 mg (60 mg/mL)
Drug: Degarelix
Degarelix 240 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Name: FE200486
Experimental: Degarelix 320 mg (60 mg/mL)
Degarelix 320 mg (60 mg/mL)
Drug: Degarelix
Degarelix 320 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Name: FE200486

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 (FDA regulated intervention is therefore ticked "YES").

The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.

  Eligibility

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

Inclusion Criteria:

  • Males aged 18 or over
  • Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
  • Has completed Study FE200486 CS07
  • Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215657

Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00215657     History of Changes
Other Study ID Numbers: FE200486 CS07A
Study First Received: September 20, 2005
Results First Received: January 22, 2009
Last Updated: May 18, 2011
Health Authority: Denmark: The Ministry of the Interior and Health

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 April 17, 2014