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Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Degarelix 240/80 mg
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.
  • Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) (except for neoadjuvant hormonal therapy/ includes patients with rising PSA after prostatectomy or radiotherapy)
  • Is a male patient aged 18 years or older
  • Has a screening serum testosterone level >1.5 ng/mL
  • Has an ECOG (Eastern Cooperative Oncology Group) score of ≤ 2
  • Has a screening PSA value of ≥2 ng/mL
  • Has a life expectancy of at least 12 months

Exclusion Criteria:

  • Has had previous or is currently under hormonal management of prostate cancer. However, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months prior to Screening Visit
  • Is currently treated with a 5-α-reductase inhibitor
  • Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
  • Has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
  • Has hypersensitivity towards any component of the investigational medicinal product
  • A marked baseline prolongation of QT/QTcF interval
  • A history of additional risk factors for Torsade de Pointes ventricular arrhythmias
  • Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
  • Has a known or suspect hepatic, symptomatic biliary disease
  • Has elevated serum ALT level more than the upper limit of normal or serum total bilirubin level above the upper level of normal range at the Screening Visit and confirmed with a second measurement within 21 days
  • Has other clinically significant laboratory abnormalities
  • Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse
  • Has a mental incapacity or language barriers precluding adequate understanding or co- operation
  • Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial
  • Has previously participated in any degarelix trial

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Degarelix 240/80 mg

Arm Description

The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.

Outcomes

Primary Outcome Measures

Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196

Secondary Outcome Measures

Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3
Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196
Cumulative Probability of no PSA Failure From Day 28 to Day 196
PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
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 percentage of participants in either group with abnormal value are presented, more variables were included in the study.
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 table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.

Full Information

First Posted
February 18, 2010
Last Updated
January 8, 2013
Sponsor
Ferring Pharmaceuticals
Collaborators
Ferring Pharmaceuticals Korea, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01071915
Brief Title
Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer
Official Title
An Open-label, Multi-Centre Trial, Bridging Efficacy and Safety of Degarelix One-Month Dosing Regimen in Korean Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (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 efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results.

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
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix 240/80 mg
Arm Type
Experimental
Arm Description
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Intervention Type
Drug
Intervention Name(s)
Degarelix 240/80 mg
Other Intervention Name(s)
FE200486, FIRMAGON
Intervention Description
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Primary Outcome Measure Information:
Title
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196
Time Frame
Day 28 to Day 196
Secondary Outcome Measure Information:
Title
Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3
Time Frame
At day 3
Title
Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28
Time Frame
To Day 28
Title
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196
Time Frame
Day 56 to Day 196
Title
Cumulative Probability of no PSA Failure From Day 28 to Day 196
Description
PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
Time Frame
To Day 196
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 percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Time Frame
To Day 196
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 table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Time Frame
To Day 196

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. Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) (except for neoadjuvant hormonal therapy/ includes patients with rising PSA after prostatectomy or radiotherapy) Is a male patient aged 18 years or older Has a screening serum testosterone level >1.5 ng/mL Has an ECOG (Eastern Cooperative Oncology Group) score of ≤ 2 Has a screening PSA value of ≥2 ng/mL Has a life expectancy of at least 12 months Exclusion Criteria: Has had previous or is currently under hormonal management of prostate cancer. However, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months prior to Screening Visit Is currently treated with a 5-α-reductase inhibitor Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy Has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema Has hypersensitivity towards any component of the investigational medicinal product A marked baseline prolongation of QT/QTcF interval A history of additional risk factors for Torsade de Pointes ventricular arrhythmias Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin Has a known or suspect hepatic, symptomatic biliary disease Has elevated serum ALT level more than the upper limit of normal or serum total bilirubin level above the upper level of normal range at the Screening Visit and confirmed with a second measurement within 21 days Has other clinically significant laboratory abnormalities Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse Has a mental incapacity or language barriers precluding adequate understanding or co- operation Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial Has previously participated in any degarelix 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
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
Kyoungbuk National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Health System (Sevrance Hospital)
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Health System Gangnam Sevrance
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer

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