NCT00215657

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Mar 2003

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

June 12, 2009

Completed
Last Updated

May 20, 2011

Status Verified

May 1, 2011

Enrollment Period

3 years

First QC Date

September 20, 2005

Results QC Date

January 22, 2009

Last Update Submit

May 18, 2011

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Liver Function Tests

    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.

    3 years

  • Participants With Markedly Abnormal Change in Vital Signs and Body Weight

    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.

    3 years

Study Arms (8)

Degarelix 120 mg (20 mg/mL)

EXPERIMENTAL

Degarelix 120 mg (20 mg/mL)

Drug: Degarelix

Degarelix 120 mg (40 mg/mL)

EXPERIMENTAL

Degarelix 120 mg (40 mg/mL)

Drug: Degarelix

Degarelix 160 mg (40 mg/mL)

EXPERIMENTAL

Degarelix 160 mg (40 mg/mL)

Drug: Degarelix

Degarelix 200 mg (40 mg/mL)

EXPERIMENTAL

Degarelix 200 mg (40 mg/mL)

Drug: Degarelix

Degarelix 200 mg (60 mg/mL)

EXPERIMENTAL

Degarelix 200 mg (60 mg/mL)

Drug: Degarelix

Degarelix 240 mg (40 mg/mL)

EXPERIMENTAL

Degarelix 240 mg (40 mg/mL)

Drug: Degarelix

Degarelix 240 mg (60 mg/mL)

EXPERIMENTAL

Degarelix 240 mg (60 mg/mL)

Drug: Degarelix

Degarelix 320 mg (60 mg/mL)

EXPERIMENTAL

Degarelix 320 mg (60 mg/mL)

Drug: Degarelix

Interventions

DegarelixDRUG

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).

Also known as: FE200486
Degarelix 120 mg (20 mg/mL)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Ferring Pharmaceuticals
Organization
Clinical Development Support
DK0-Disclosure@ferring.com

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

March 1, 2003

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

May 20, 2011

Results First Posted

June 12, 2009

Record last verified: 2011-05