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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Degarelix

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Kyoungbuk National University Hospital
  • Anam-dong, Seongbuk-gu
    • Seoul, Anam-dong, Seongbuk-gu, Korea, Republic of
      • Korea University Hospital
  • Banpo-dong, Seocho-gu
    • Seoul, Banpo-dong, Seocho-gu, Korea, Republic of
      • Seoul St. Mary's Hospital
  • Eonguro, Gangnam-gu
    • Seoul, Eonguro, Gangnam-gu, Korea, Republic of
      • Yonsei University Health System Gangnam Sevrance
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of
      • Seoul National University Bundang Hospital
  • Gyunggi-do
    • Pyungchon, Gyunggi-do, Korea, Republic of
      • Hallym University Sacred Heart Hospital
  • Gyungnam
    • Mulgeum-eup, Gyungnam, Korea, Republic of
      • Pusan National University Yangsan Hospital
  • Ilwon-dong, Kangnam-gu
    • Seoul, Ilwon-dong, Kangnam-gu, Korea, Republic of
      • Samsung Medical Center
  • Pungnap-2-dong, Songpa-gu
    • Seoul, Pungnap-2-dong, Songpa-gu, Korea, Republic of
      • Asan Medical Center
  • Seongsanno, Seodaemun-gu
    • Seoul, Seongsanno, Seodaemun-gu, Korea, Republic of
      • Yonsei University Health System (Sevrance Hospital)
  • Yeongeon-dong, Chongno-gu
    • Seoul, Yeongeon-dong, Chongno-gu, Korea, Republic of
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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• Has been withdrawn/discontinued from the FE200486 CS42 trial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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Degarelix	Drug: Degarelix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Collaborators: Ferring Pharmaceuticals Korea, Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: October 5, 2010
• First Submitted That Met QC Criteria: October 5, 2010
• First Posted (Estimate): October 6, 2010

Study Record Updates

• Last Update Posted (Estimate): May 22, 2013
• Last Update Submitted That Met QC Criteria: April 4, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: FE200486 CS42A