Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117949
• Other study ID #: FE200486 CS06
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2005
• Last updated: May 18, 2011
• Start date: April 2002
• Est. completion date: January 2004

Study information

• Verified date: May 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
• Degarelix
One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.
• Degarelix
One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.
• Degarelix
One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.

Locations

Country	Name	City	State
United States	Advanced Urology Medical Center	Anaheim	California
United States	Urology Clinics of NorthTexas, PA	Dallas	Texas
United States	Urology Associate PC`	Denver	Colorado
United States	SW Florida Urological Associates	Fort Myers	Florida
United States	Drs. Werner, Murdock & Francis, PA	Greenbelt	Maryland
United States	South Orange County Medical Research Center	Laguna Woods,	California
United States	Nevada Urology Associates	Reno	Nevada
United States	Urology San Antonio Research	San Antonio	Texas
United States	San Bernardino Urological Associates Medical Group	San Bernardino	California
United States	Pinellas Urology, Inc.	St. Petersburg	Florida
United States	Western Clinical Research	Torrance	California
United States	Urology Specialists of Oklahoma, Inc.	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No