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

This study has been completed.
Sponsor:
Collaborator:
Ferring Pharmaceuticals Korea, Ltd.
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01071915
First received: February 18, 2010
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix 240/80 mg
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196 [ Time Frame: Day 28 to Day 196 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3 [ Time Frame: At day 3 ] [ Designated as safety issue: No ]
  • Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28 [ Time Frame: To Day 28 ] [ Designated as safety issue: No ]
  • Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196 [ Time Frame: Day 56 to Day 196 ] [ Designated as safety issue: No ]
  • Cumulative Probability of no PSA Failure From Day 28 to Day 196 [ Time Frame: To Day 196 ] [ Designated as safety issue: No ]
    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 [ Time Frame: To Day 196 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: To Day 196 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 157
Study Start Date: March 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Degarelix 240/80 mg
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.
Drug: Degarelix 240/80 mg
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.
Other Names:
  • FE200486
  • FIRMAGON

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071915

Locations
Korea, Republic of
Hallym University Sacred Heart Hospital
Pyungchon, Gyunggi-do, Korea, Republic of
Pusan National University Yangsan Hospital
Mulgeum-eup, Gyungnam, Korea, Republic of
Kyoungbuk National University Hospital
Daegu, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Korea University Hospital
Seoul, Korea, Republic of
Yonsei University Health System Gangnam Sevrance
Seoul, Korea, Republic of
Yonsei University Health System (Sevrance Hospital)
Seoul, Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring Pharmaceuticals Korea, Ltd.
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01071915     History of Changes
Other Study ID Numbers: FE200486 CS42
Study First Received: February 18, 2010
Results First Received: October 29, 2012
Last Updated: January 8, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 19, 2014