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

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix

• Registration Number: NCT01215513
• Lead Sponsor: Ferring Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-05
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-06
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-04
• Results First Submitted: 2013-04-04
• Results First Submitted QC: 2013-04-04
• Last Update Submitted: 2013-04-04
• Results First Posted: 2013-05-22
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 127

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• Has been withdrawn/discontinued from the FE200486 CS42 trial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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Degarelix	Degarelix	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables	From baseline (day 0) to end of treatment (up to day 364)	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
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	From baseline (day 0) to end of treatment (up to day 364)	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.
Number of Participants With Markedly Abnormal Values in ECG Variables	From baseline (day 0) to end of treatment (up to day 364)	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.

Secondary Outcome Measures

Name	Time	Method
Serum Levels of Prostate Specific Antigen (PSA) Over Time	Day 0, day 196, day 280, and day 364	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).

Trial Locations

Locations (11)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of

Kyoungbuk National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Yonsei University Health System Gangnam Sevrance; 🇰🇷 Seoul, Eonguro, Gangnam-gu, Korea, Republic of

Korea University Hospital; 🇰🇷 Seoul, Anam-dong, Seongbuk-gu, Korea, Republic of

Yonsei University Health System (Sevrance Hospital); 🇰🇷 Seoul, Seongsanno, Seodaemun-gu, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Pyungchon, Gyunggi-do, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Mulgeum-eup, Gyungnam, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Pungnap-2-dong, Songpa-gu, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Yeongeon-dong, Chongno-gu, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Ilwon-dong, Kangnam-gu, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Banpo-dong, Seocho-gu, Korea, Republic of