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

Prostate Cancer Clinical Trial

Official title:

An Open-label, Multi-Centre Trial, Bridging Efficacy and Safety of Degarelix One-Month Dosing Regimen in Korean Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071915
• Other study ID #: FE200486 CS42
• Status: Completed
• Phase: Phase 3
• First received: February 18, 2010
• Last updated: January 8, 2013
• Start date: March 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2013
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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-a-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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Kyoungbuk National University Hospital	Daegu
Korea, Republic of	Pusan National University Yangsan Hospital	Mulgeum-eup	Gyungnam
Korea, Republic of	Hallym University Sacred Heart Hospital	Pyungchon	Gyunggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Yonsei University Health System (Sevrance Hospital)	Seoul
Korea, Republic of	Yonsei University Health System Gangnam Sevrance	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals	Ferring Pharmaceuticals Korea, Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Probability of Testosterone at Castrate Level (=0.5 ng/mL) From Day 28 to Day 196		Day 28 to Day 196	No
Secondary	Proportion of Patients With Testosterone Level =0.5 ng/mL at Day 3		At day 3	No
Secondary	Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28		To Day 28	No
Secondary	Cumulative Probability of Testosterone at Castrate Level (=0.5 ng/mL)From Day 56 to Day 196		Day 56 to Day 196	No
Secondary	Cumulative Probability of no PSA Failure From Day 28 to Day 196	PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.	To Day 196	No
Secondary	Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables	The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.	To Day 196	Yes
Secondary	Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.	To Day 196	Yes