Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer

NCT ID: NCT01071915

Last Updated: 2013-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-11-30

Brief Summary

This is an open-label, multi-centre single arm trial to investigate efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Degarelix 240/80 mg

The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.

Group Type: EXPERIMENTAL

Degarelix 240/80 mg

Intervention Type: DRUG

The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.

Interventions

Degarelix 240/80 mg

The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.

Intervention Type: DRUG

Other Intervention Names

FE200486; FIRMAGON

Eligibility Criteria

Inclusion Criteria

• Has given written informed consent before any trial-related activity is performed.
• Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) (except for neoadjuvant hormonal therapy/ includes patients with rising PSA after prostatectomy or radiotherapy)
• Is a male patient aged 18 years or older
• Has a screening serum testosterone level >1.5 ng/mL
• Has an ECOG (Eastern Cooperative Oncology Group) score of ≤ 2
• Has a screening PSA value of ≥2 ng/mL
• Has a life expectancy of at least 12 months

Exclusion Criteria

• Has had previous or is currently under hormonal management of prostate cancer. However, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months prior to Screening Visit
• Is currently treated with a 5-α-reductase inhibitor
• Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
• Has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
• Has hypersensitivity towards any component of the investigational medicinal product
• A marked baseline prolongation of QT/QTcF interval
• A history of additional risk factors for Torsade de Pointes ventricular arrhythmias
• Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
• Has a known or suspect hepatic, symptomatic biliary disease
• Has elevated serum ALT level more than the upper limit of normal or serum total bilirubin level above the upper level of normal range at the Screening Visit and confirmed with a second measurement within 21 days
• Has other clinically significant laboratory abnormalities
• Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse
• Has a mental incapacity or language barriers precluding adequate understanding or co- operation
• Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial
• Has previously participated in any degarelix trial

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

Sponsors

Ferring Pharmaceuticals Korea, Ltd.

OTHER

Sponsor Role: collaborator

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Kyoungbuk National University Hospital

Daegu, Daegu, South Korea

Hallym University Sacred Heart Hospital

Pyungchon, Gyunggi-do, South Korea

Pusan National University Yangsan Hospital

Mulgeum-eup, Gyungnam, South Korea

Seoul National University Bundang Hospital

Seongnam, , South Korea

Asan Medical Center

Seoul, , South Korea

Korea University Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Seoul St. Mary's Hospital

Seoul, , South Korea

Yonsei University Health System (Sevrance Hospital)

Seoul, , South Korea

Yonsei University Health System Gangnam Sevrance

Seoul, , South Korea

Countries

South Korea

Other Identifiers

FE200486 CS42

Identifier Type: -

Identifier Source: org_study_id