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

September 20, 2005
May 18, 2011
March 2003
March 2006   (final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT00215657 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

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

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Experimental: Degarelix 120 mg (20 mg/mL)
    Degarelix 120 mg (20 mg/mL)
    Intervention: Drug: Degarelix
  • Experimental: Degarelix 120 mg (40 mg/mL)
    Degarelix 120 mg (40 mg/mL)
    Intervention: Drug: Degarelix
  • Experimental: Degarelix 160 mg (40 mg/mL)
    Degarelix 160 mg (40 mg/mL)
    Intervention: Drug: Degarelix
  • Experimental: Degarelix 200 mg (40 mg/mL)
    Degarelix 200 mg (40 mg/mL)
    Intervention: Drug: Degarelix
  • Experimental: Degarelix 200 mg (60 mg/mL)
    Degarelix 200 mg (60 mg/mL)
    Intervention: Drug: Degarelix
  • Experimental: Degarelix 240 mg (40 mg/mL)
    Degarelix 240 mg (40 mg/mL)
    Intervention: Drug: Degarelix
  • Experimental: Degarelix 240 mg (60 mg/mL)
    Degarelix 240 mg (60 mg/mL)
    Intervention: Drug: Degarelix
  • Experimental: Degarelix 320 mg (60 mg/mL)
    Degarelix 320 mg (60 mg/mL)
    Intervention: Drug: Degarelix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
131
March 2006
March 2006   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00215657
FE200486 CS07A
No
Clinical Development Support, Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP