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

NCT01071915 | Completed Phase 3 Results

• 1 other identifier: FE200486 CS42
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 11

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

Outcome Measures

Primary Outcomes (1)

• Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196

  Day 28 to Day 196

Secondary Outcomes (6)

• Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3

  At day 3

• Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28

  To Day 28

• Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196

  Day 56 to Day 196

• Cumulative Probability of no PSA Failure From Day 28 to Day 196

  To Day 196

• Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables

  To Day 196

Study Arms (1)

Degarelix 240/80 mg

EXPERIMENTAL

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.

Drug: Degarelix 240/80 mg

Interventions

Degarelix 240/80 mg 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.

Also known as: FE200486, FIRMAGON

Degarelix 240/80 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead
• Ferring Pharmaceuticals Korea, Ltd.: collaborator

Study Sites (11)

Kyoungbuk National University Hospital

Daegu, Daegu, South Korea

Location

Hallym University Sacred Heart Hospital

Pyungchon, Gyunggi-do, South Korea

Location

Pusan National University Yangsan Hospital

Mulgeum-eup, Gyungnam, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Korea University Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Seoul St. Mary's Hospital

Seoul, South Korea

Location

Yonsei University Health System (Sevrance Hospital)

Seoul, South Korea

Location

Yonsei University Health System Gangnam Sevrance

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ferring Pharmaceuticals
• Organization: Clinical Development Support

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 12, 2013
• Results First Posted: February 12, 2013

Record last verified: 2013-01

Locations

KR (11)