Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients

Prostate Cancer Clinical Trial

Official title:

An Open-Label, Multi-Centre, Extension Trial, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients Requiring Androgen Ablation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215513
• Other study ID #: FE200486 CS42A
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2010
• Last updated: April 4, 2013
• Start date: September 2010
• Est. completion date: April 2012

Study information

• Verified date: April 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 long-term safety and tolerability of degarelix in Korean patients with prostate cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• 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. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient

• Has completed the 7-month main trial, FE200486 CS42

Exclusion Criteria:

• Has been withdrawn/discontinued from the FE200486 CS42 trial

• A patient may also not be entered into the CS42A trial at the discretion of the investigator due to safety or lack of efficacy concerns (LH or PSA response) in the CS42 trial.

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Drug:
• Degarelix

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	Gyeonggi
Korea, Republic of	Asan Medical Center	Seoul	Pungnap-2-dong, Songpa-gu
Korea, Republic of	Korea University Hospital	Seoul	Anam-dong, Seongbuk-gu
Korea, Republic of	Samsung Medical Center	Seoul	Ilwon-dong, Kangnam-gu
Korea, Republic of	Seoul National University Hospital	Seoul	Yeongeon-dong, Chongno-gu
Korea, Republic of	Seoul St. Mary's Hospital	Seoul	Banpo-dong, Seocho-gu
Korea, Republic of	Yonsei University Health System (Sevrance Hospital)	Seoul	Seongsanno, Seodaemun-gu
Korea, Republic of	Yonsei University Health System Gangnam Sevrance	Seoul	Eonguro, Gangnam-gu

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	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 participant with abnormal value are presented, more variables were included in the study.; ULN=upper limit of normal	From baseline (day 0) to end of treatment (up to day 364)	No
Primary	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 figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.	From baseline (day 0) to end of treatment (up to day 364)	No
Primary	Number of Participants With Markedly Abnormal Values in ECG Variables	This outcome measure included incidence of markedly abnormal changes in ECG variables (PR, QRS, and QT interval, QTcF, and ventricular rate). The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.	From baseline (day 0) to end of treatment (up to day 364)	No
Secondary	Serum Levels of Prostate Specific Antigen (PSA) Over Time	PSA levels were measured over time. The figures present the median level at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).	Day 0, day 196, day 280, and day 364	No