Clinical trial NCT00117949: Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486
Official title: An Open-Label, Multi-Center, Ascending, Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Androgen ablation therapy
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-07-11
Enrollment: 82
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Time to Meet Insufficient Testosterone Response
timeFrame: 3 months
measure: Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days
timeFrame: 28 days
Secondary outcomes:
measure: Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).
timeFrame: 1, 3, 7, 14, 21, 28, 42 days
measure: Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days
timeFrame: 3 months
measure: Time to 50% Reduction in Prostate-specific Antigen Levels
timeFrame: 3 months
measure: Time to 90% Reduction in Prostate-specific Antigen Levels
timeFrame: 3 months
measure: Liver Function Tests
timeFrame: 3 months
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Urology Medical Center
state: California
city: Laguna Woods,
country: United States
facility: South Orange County Medical Research Center
state: California
city: San Bernardino
country: United States
facility: San Bernardino Urological Associates Medical Group
state: California
city: Torrance
country: United States
facility: Western Clinical Research
state: California
city: Denver
country: United States
facility: Urology Associate PC'
state: Colorado
city: Fort Myers
country: United States
facility: SW Florida Urological Associates
state: Florida
city: St. Petersburg
country: United States
facility: Pinellas Urology, Inc.
state: Florida
city: Greenbelt
country: United States
facility: Drs. Werner, Murdock & Francis, PA
state: Maryland
city: Reno
country: United States
facility: Nevada Urology Associates
state: Nevada
city: Tulsa
country: United States
facility: Urology Specialists of Oklahoma, Inc.
state: Oklahoma
city: Dallas
country: United States
facility: Urology Clinics of NorthTexas, PA
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: