Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

An Open-Label, Multi-Center, Ascending, Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Degarelix; Drug: Degarelix; Drug: Degarelix; Drug: Degarelix

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: FE200486; Drug: Degarelix; One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.; Other Names: FE200486; Drug: Degarelix; One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.; Other Names: FE200486; Drug: Degarelix; One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.; Other Names: FE200486
Experimental: Degarelix 80 mg; Degarelix 80 mg (20 mg/mL)	Drug: Degarelix; One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.; Other Names: FE200486; Drug: Degarelix; One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.; Other Names: FE200486; Drug: Degarelix; One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.; Other Names: FE200486; Drug: Degarelix; One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.; Other Names: FE200486
Experimental: Degarelix 120 mg; Degarelix 120 mg (30 mg/mL)	Drug: Degarelix; One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.; Other Names: FE200486; Drug: Degarelix; One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.; Other Names: FE200486; Drug: Degarelix; One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.; Other Names: FE200486; Drug: Degarelix; One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.; Other Names: FE200486
Experimental: Degarelix 160 mg; Degarelix 160 mg (40 mg/mL)	Drug: Degarelix; One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.; Other Names: FE200486; Drug: Degarelix; One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.; Other Names: FE200486; Drug: Degarelix; One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.; Other Names: FE200486; Drug: Degarelix; One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.; Other Names: FE200486

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Meet Insufficient Testosterone Response	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.	3 months
Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days	The number of participants suppressed for at least 28 days was defined as the estimated "survival probability" at time=Day 28.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).	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.	1, 3, 7, 14, 21, 28, 42 days
Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days	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.	3 months
Time to 50% Reduction in Prostate-specific Antigen Levels	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.	3 months
Time to 90% Reduction in Prostate-specific Antigen Levels	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.	3 months
Liver Function Tests	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.	3 months

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Primary Completion (Actual): January 1, 2004
• Study Completion (Actual): January 1, 2004

Study Registration Dates

• First Submitted: June 30, 2005
• First Submitted That Met QC Criteria: June 30, 2005
• First Posted (Estimate): July 11, 2005

Study Record Updates

• Last Update Posted (Estimate): May 23, 2011
• Last Update Submitted That Met QC Criteria: May 18, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Prostate Cancer; Androgen ablation therapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: FE200486 CS06