Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients
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
1 other identifier
interventional
127
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 prostate-cancer
Started Sep 2010
Shorter than P25 for phase_3 prostate-cancer
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 5, 2010
CompletedFirst Posted
Study publicly available on registry
October 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
May 22, 2013
CompletedMay 22, 2013
April 1, 2013
1.6 years
October 5, 2010
April 4, 2013
April 4, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
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)
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)
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)
Secondary Outcomes (1)
Serum Levels of Prostate Specific Antigen (PSA) Over Time
Day 0, day 196, day 280, and day 364
Study Arms (1)
Degarelix
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ferring Pharmaceuticalslead
- Ferring Pharmaceuticals Korea, Ltd.collaborator
Study Sites (11)
Korea University Hospital
Seoul, Anam-dong, Seongbuk-gu, South Korea
Seoul St. Mary's Hospital
Seoul, Banpo-dong, Seocho-gu, South Korea
Kyoungbuk National University Hospital
Daegu, Daegu, South Korea
Yonsei University Health System Gangnam Sevrance
Seoul, Eonguro, Gangnam-gu, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Hallym University Sacred Heart Hospital
Pyungchon, Gyunggi-do, South Korea
Pusan National University Yangsan Hospital
Mulgeum-eup, Gyungnam, South Korea
Samsung Medical Center
Seoul, Ilwon-dong, Kangnam-gu, South Korea
Asan Medical Center
Seoul, Pungnap-2-dong, Songpa-gu, South Korea
Yonsei University Health System (Sevrance Hospital)
Seoul, Seongsanno, Seodaemun-gu, South Korea
Seoul National University Hospital
Seoul, Yeongeon-dong, Chongno-gu, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Support
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
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
October 5, 2010
First Posted
October 6, 2010
Study Start
September 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
May 22, 2013
Results First Posted
May 22, 2013
Record last verified: 2013-04