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
Overview
- Phase
- Phase 3
- Intervention
- Degarelix
- Conditions
- Prostate Cancer
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 127
- Locations
- 11
- Primary Endpoint
- Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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- •Has been withdrawn/discontinued from the FE200486 CS42 trial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.
Arms & Interventions
Degarelix
Intervention: Degarelix
Outcomes
Primary Outcomes
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Serum Levels of Prostate Specific Antigen (PSA) Over Time(Day 0, day 196, day 280, and day 364)