Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: Degarelix	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Multi-Center, Ascending, Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

Resource links provided by NLM:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: Prostate Cancer

Drug Information available for: Degarelix

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Time to Meet Insufficient Testosterone Response [ Time Frame: 3 months ]
Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days [ Time Frame: 28 days ]
The number of participants suppressed for at least 28 days was defined as the estimated "survival probability" at time=Day 28.

Secondary Outcome Measures:

Time to Testosterone Castration (Testosterone ≤0.5 ng/mL). [ Time Frame: 1, 3, 7, 14, 21, 28, 42 days ]
Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. The figures in the table present the number of participants who were castrated after 1, 3, 7, 14, 21, 28, and 42 days.
Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days [ Time Frame: 3 months ]
Sufficient testosterone suppression was defined as not meeting an insufficient testosterone response criterion. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
Time to 50% Reduction in Prostate-specific Antigen Levels [ Time Frame: 3 months ]
The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 50% reduction in PSA level was reached.
Time to 90% Reduction in Prostate-specific Antigen Levels [ Time Frame: 3 months ]
The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 90% reduction in PSA level was reached.
Liver Function Tests [ Time Frame: 3 months ]
The number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferas 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.


Enrollment:	82
Study Start Date:	April 2002
Study Completion Date:	January 2004
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Degarelix 40 mg Degarelix 40 mg (10 mg/mL)	Drug: Degarelix One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection. Other Name: FE200486
Experimental: Degarelix 80 mg Degarelix 80 mg (20 mg/mL)	Drug: Degarelix One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection. Other Name: FE200486
Experimental: Degarelix 120 mg Degarelix 120 mg (30 mg/mL)	Drug: Degarelix One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection. Other Name: FE200486
Experimental: Degarelix 160 mg Degarelix 160 mg (40 mg/mL)	Drug: Degarelix One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection. Other Name: FE200486

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Each patient must meet the following inclusion criteria before entry into the study:

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:

Any patient meeting one or more of the following exclusion criteria will not be entered into the study:

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117949

Locations


United States, California
Advanced Urology Medical Center
Anaheim, California, United States, 92801
South Orange County Medical Research Center
Laguna Woods,, California, United States, 92653
San Bernardino Urological Associates Medical Group
San Bernardino, California, United States, 92404
Western Clinical Research
Torrance, California, United States, 90505
United States, Colorado
Urology Associate PC`
Denver, Colorado, United States, 80210
United States, Florida
SW Florida Urological Associates
Fort Myers, Florida, United States, 33907
Pinellas Urology, Inc.
St. Petersburg, Florida, United States, 33710
United States, Maryland
Drs. Werner, Murdock & Francis, PA
Greenbelt, Maryland, United States, 20770
United States, Nevada
Nevada Urology Associates
Reno, Nevada, United States, 89511
United States, Oklahoma
Urology Specialists of Oklahoma, Inc.
Tulsa, Oklahoma, United States, 74104
United States, Texas
Urology Clinics of NorthTexas, PA
Dallas, Texas, United States, 75231
Urology San Antonio Research
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators


Study Director:	Clinical Development Support	Ferring Pharmaceuticals

More Information


Responsible Party:	Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00117949 History of Changes
Other Study ID Numbers:	FE200486 CS06
Study First Received:	June 30, 2005
Results First Received:	January 22, 2009
Last Updated:	May 18, 2011

Keywords provided by Ferring Pharmaceuticals:


Prostate Cancer Androgen ablation therapy

Additional relevant MeSH terms:


Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site	Neoplasms Genital Diseases, Male Prostatic Diseases

ClinicalTrials.gov processed this record on July 17, 2017