Clinical trial NCT01215513: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Ferring Pharmaceuticals Korea, Ltd.
First posted: 2010-10-06
Enrollment: 127
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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* Has been withdrawn/discontinued from the FE200486 CS42 trial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

Primary outcomes:
measure: Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
timeFrame: From baseline (day 0) to end of treatment (up to day 364)
measure: Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
timeFrame: From baseline (day 0) to end of treatment (up to day 364)
measure: Number of Participants With Markedly Abnormal Values in ECG Variables
timeFrame: From baseline (day 0) to end of treatment (up to day 364)
Secondary outcomes:
measure: Serum Levels of Prostate Specific Antigen (PSA) Over Time
timeFrame: Day 0, day 196, day 280, and day 364
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Hospital
state: Anam-dong, Seongbuk-gu
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Banpo-dong, Seocho-gu
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Gangnam Sevrance
state: Eonguro, Gangnam-gu
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
city: Pyungchon
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyunggi-do
city: Mulgeum-eup
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyungnam
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Ilwon-dong, Kangnam-gu
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Pungnap-2-dong, Songpa-gu
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System (Sevrance Hospital)
state: Seongsanno, Seodaemun-gu
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Yeongeon-dong, Chongno-gu
city: Daegu
country: Korea, Republic of
facility: Kyoungbuk National University Hospital
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: