Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients

NCT00245466 | Terminated Phase 2 Results

• 1 other identifier: FE200486 CS02A
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Androgen ablation therapy

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

Secondary Outcomes (1)

• Serum Levels of Testosterone After 1, 2, and 3 Years

  3 years

Study Arms (3)

Degarelix 80/80 + 40

EXPERIMENTAL

In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

Drug: Degarelix

Degarelix 40/40 + 40

EXPERIMENTAL

In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

Drug: Degarelix

Degarelix 80 + 20

EXPERIMENTAL

In the main study (FE200486 CS02; NCT00819247) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

Drug: Degarelix

Interventions

Degarelix DRUG

Given as a subcutaneous injection once every 4 weeks.

Also known as: FE200486

Degarelix 80/80 + 40

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has completed study treatment in study FE200486 CS02.
• Has completed visit 16 in study FE200486 CS02.
• Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

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, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male 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: October 26, 2005
• First Posted: October 28, 2005
• Study Start: October 1, 2001
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: May 20, 2011
• Results First Posted: June 11, 2009

Record last verified: 2011-05