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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Degarelix
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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  • Has been withdrawn/discontinued from the FE200486 CS42 trial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

Sites / Locations

  • Korea University Hospital
  • Seoul St. Mary's Hospital
  • Yonsei University Health System Gangnam Sevrance
  • Seoul National University Bundang Hospital
  • Hallym University Sacred Heart Hospital
  • Pusan National University Yangsan Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Yonsei University Health System (Sevrance Hospital)
  • Seoul National University Hospital
  • Kyoungbuk National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Degarelix

Arm Description

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

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).

Full Information

First Posted
October 5, 2010
Last Updated
April 4, 2013
Sponsor
Ferring Pharmaceuticals
Collaborators
Ferring Pharmaceuticals Korea, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01215513
Brief Title
Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals
Collaborators
Ferring Pharmaceuticals Korea, Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Degarelix
Primary Outcome Measure Information:
Title
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Description
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
Time Frame
From baseline (day 0) to end of treatment (up to day 364)
Title
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Description
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.
Time Frame
From baseline (day 0) to end of treatment (up to day 364)
Title
Number of Participants With Markedly Abnormal Values in ECG Variables
Description
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.
Time Frame
From baseline (day 0) to end of treatment (up to day 364)
Secondary Outcome Measure Information:
Title
Serum Levels of Prostate Specific Antigen (PSA) Over Time
Description
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).
Time Frame
Day 0, day 196, day 280, and day 364

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Korea University Hospital
City
Seoul
State/Province
Anam-dong, Seongbuk-gu
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
State/Province
Banpo-dong, Seocho-gu
Country
Korea, Republic of
Facility Name
Yonsei University Health System Gangnam Sevrance
City
Seoul
State/Province
Eonguro, Gangnam-gu
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
Pyungchon
State/Province
Gyunggi-do
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Mulgeum-eup
State/Province
Gyungnam
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Ilwon-dong, Kangnam-gu
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
State/Province
Pungnap-2-dong, Songpa-gu
Country
Korea, Republic of
Facility Name
Yonsei University Health System (Sevrance Hospital)
City
Seoul
State/Province
Seongsanno, Seodaemun-gu
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Yeongeon-dong, Chongno-gu
Country
Korea, Republic of
Facility Name
Kyoungbuk National University Hospital
City
Daegu
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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