Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

NCT ID: NCT00117949

Last Updated: 2011-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2004-01-31

Brief Summary

Population pharmacokinetic and pharmacodynamic data from Study FE200486 CS06 and FE200486 CS02 provided further knowledge of the optimal dose regimens for FE200486 (degarelix). Both studies were to guide dose selection for phase III. In addition, safety and tolerance data were generated.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Degarelix 40 mg

Degarelix 40 mg (10 mg/mL)

Group Type: EXPERIMENTAL

Degarelix

Intervention Type: DRUG

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

Degarelix 80 mg

Degarelix 80 mg (20 mg/mL)

Group Type: EXPERIMENTAL

Degarelix

Intervention Type: DRUG

One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.

Degarelix 120 mg

Degarelix 120 mg (30 mg/mL)

Group Type: EXPERIMENTAL

Degarelix

Intervention Type: DRUG

One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.

Degarelix 160 mg

Degarelix 160 mg (40 mg/mL)

Group Type: EXPERIMENTAL

Degarelix

Intervention Type: DRUG

One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.

Interventions

Degarelix

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

Intervention Type: DRUG

Degarelix

One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.

Intervention Type: DRUG

Degarelix

One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.

Intervention Type: DRUG

Degarelix

One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.

Intervention Type: DRUG

Other Intervention Names

FE200486; FE200486; FE200486; FE200486

Eligibility Criteria

Inclusion Criteria

• 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.)
• Is a male patient with histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment is indicated, except for neoadjuvant hormonal therapy. For patients, prostate-specific antigen (PSA) increases on two consecutive determinations at least 2 weeks apart prior to Visit 1 must be documented.
• Is at least 18 years.
• Has an ECOG score of 2.
• Has a baseline testosterone level within the age specific normal range as measured by the central laboratory.
• Has a PSA value of 2 ng/mL as measured by the central laboratory.
• Has a life expectancy of at least 6 months.

Exclusion Criteria

• Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens, PC-Spec) except for neoadjuvant hormonal therapy of < 6 months duration and completed > 6 months prior to Visit 1.
• Requires hormonal therapy for neoadjuvant purposes.
• Is recently (within the last 12 weeks preceding Visit 1) or presently treated 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 must be within normal limits).
• Has a mental incapacity or language barrier precluding adequate understanding or co-operation.
• Has received an investigational drug within the last 12 weeks preceding Visit 1.
• Has previously participated in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Ferring Pharmaceuticals

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Advanced Urology Medical Center

Anaheim, California, United States

South Orange County Medical Research Center

Laguna Woods, California, United States

San Bernardino Urological Associates Medical Group

San Bernardino, California, United States

Western Clinical Research

Torrance, California, United States

Urology Associate PC'

Denver, Colorado, United States

SW Florida Urological Associates

Fort Myers, Florida, United States

Pinellas Urology, Inc.

St. Petersburg, Florida, United States

Drs. Werner, Murdock & Francis, PA

Greenbelt, Maryland, United States

Nevada Urology Associates

Reno, Nevada, United States

Urology Specialists of Oklahoma, Inc.

Tulsa, Oklahoma, United States

Urology Clinics of NorthTexas, PA

Dallas, Texas, United States

Urology San Antonio Research

San Antonio, Texas, United States

Countries

United States

Other Identifiers

FE200486 CS06

Identifier Type: -

Identifier Source: org_study_id