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

NCT00117312 | Terminated Phase 2 Results DMC

• 1 other identifier: FE200486 CS06A
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 12

Brief Summary

Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity to continue treatment with degarelix under a clinical study until FE200486 was available on the market or until the study was discontinued. Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of FE200486.

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 participants in each group with normal baseline and markedly abnormal value post-baseline.

  3 years

Study Arms (4)

Degarelix 40 mg

EXPERIMENTAL

Degarelix 40 mg (10 mg/mL)

Drug: Degarelix

Degarelix 80 mg

EXPERIMENTAL

Degarelix 80 mg (20 mg/mL)

Drug: Degarelix

Degarelix 120 mg

EXPERIMENTAL

Degarelix 120 mg (30 mg/mL)

Drug: Degarelix

Degarelix 160 mg

EXPERIMENTAL

Degarelix 160 mg (40 mg/mL)

Drug: Degarelix

Interventions

Degarelix DRUG

One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.

Also known as: FE200486

Degarelix 40 mg

Eligibility Criteria

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

You may qualify if:

• Has given written consent before any study related activity is performed. A study related activity is defined as any procedure that would not have been performed during the normal management of the patient.
• Has had sufficient testosterone suppression (as defined in the withdrawal criteria of FE200486 CS06) for at least 28 days.

You may not qualify if:

• Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen (PSA) suppression as defined in Study FE200486 CS06 in the absence of concomitant rise in testosterone level or non-compliance with protocol required procedures.
• Requires hormonal therapy for neoadjuvant purposes.
• Requires treatment with any other drug modifying the testosterone level or function.
• Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy, within 6 months after Visit 1.
• Has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions.
• Has hypersensitivity towards any component of the investigational product.
• Has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin.
• Has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study, as judged by the investigator.
• Any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases and bilirubin must be within normal limits).
• Has a mental incapacity or language barrier precluding adequate understanding or co-operation.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (12)

Advanced Urology Medical Center

Anaheim, California, 92801, United States

Location

South Orange County Medical Research Center

Laguna Woods, California, 92653, United States

Location

San Bernardino Urological Associates Medical Group

San Bernardino, California, 92404, United States

Location

Western Clinical Research

Torrance, California, 90505, United States

Location

Urology Associate PC'

Denver, Colorado, 80210, United States

Location

SW Florida Urological Associates

Fort Myers, Florida, 33907, United States

Location

Pinellas Urology, Inc.

St. Petersburg, Florida, 33710, United States

Location

Drs. Werner, Murdock & Francis, PA

Greenbelt, Maryland, 20770, United States

Location

Nevada Urology Associates

Reno, Nevada, 89511, United States

Location

Urology Specialists of Oklahoma, Inc.

Tulsa, Oklahoma, 74104, United States

Location

Urology Clinics of NorthTexas, PA

Dallas, Texas, 75231, United States

Location

Urology San Antonio Research

San Antonio, Texas, 78229, United States

Location

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: June 30, 2005
• First Posted: July 6, 2005
• Study Start: October 1, 2002
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: May 23, 2011
• Results First Posted: March 20, 2009

Record last verified: 2011-05

Locations

US (12)