Primary outcomeMean· Day 28 to Day 196
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196
| Group | Value (percent probability) |
|---|---|
| Degarelix 240/80 mg | 96.7 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataEfficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer
NCTNCT01071915 (opens ClinicalTrials.gov in a new tab)Other idFE200486 CS42
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 157 participants (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
South Korea
- Start
- Mar 2010
- Primary completion
- Nov 2011
- Completion
- Nov 2011
- First posted
- 19 Feb 2010 (estimated)
- Last update posted
- 12 Feb 2013 (estimated)
- Conditions
- Prostate Cancer
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201020112012
- Ph 3
Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer
NCT01071915Mar 2010 to Nov 2011
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Degarelix 240/80 mgDrug
Arms1
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
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 outcomes(6)
Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3
Time frame · At day 3
Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28
Time frame · To Day 28
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196
Time frame · Day 56 to Day 196
Cumulative Probability of no PSA Failure From Day 28 to Day 196
Time frame · To Day 196
Registry description
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
Registry 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.
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Time frame · To Day 196
Registry 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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeNumber· At day 3
Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3
| Group | Value (percent) |
|---|---|
| Degarelix 240/80 mg | 97.4 |
Secondary outcomeMedian· To Day 28
Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28
| Group | Value (percent) |
|---|---|
| Degarelix 240/80 mg | -79.7 |
Secondary outcomeMean· Day 56 to Day 196
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196
| Group | Value (percent probability) |
|---|---|
| Degarelix 240/80 mg | 96.7 |
Secondary outcomeMean· To Day 196
Cumulative Probability of no PSA Failure From Day 28 to Day 196
| Group | Value (percent probability) |
|---|---|
| Degarelix 240/80 mg | 97.3 |
Secondary outcomeNumber· To Day 196
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
| Group | Value (participants) |
|---|---|
| Degarelix 240/80 mg | 73 |
Secondary outcomeNumber· To Day 196
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
| Group | Value (participants) |
|---|---|
| Degarelix 240/80 mg | 6 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Degarelix 240/80 mgThe 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. | – | 18 / 156 | 113 / 156 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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