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| Name | Class |
|---|---|
| Ferring Pharmaceuticals Korea, Ltd. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline (day 0) to end of treatment (up to day 364) |
| 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. | From baseline (day 0) to end of treatment (up to day 364) |
| 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. | From baseline (day 0) to end of treatment (up to day 364) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 0, day 196, day 280, and day 364 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Hospital | Seoul | Anam-dong, Seongbuk-gu | South Korea | |||
| Seoul St. Mary's Hospital |
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The participants were recruited from 9 sites in Korea. All participants had completed the 7-month main study (CS42, NCT01071915) prior to enrollment into this extension study (CS42A). The CS42A study was conducted between 20 September 2010 (FPFV) and 25 April 2012 (LPLV).
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| ID | Title | Description |
|---|---|---|
| FG000 | Degarelix | 80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Seoul |
| Banpo-dong, Seocho-gu |
| South Korea |
| Kyoungbuk National University Hospital | Daegu | Daegu | South Korea |
| Yonsei University Health System Gangnam Sevrance | Seoul | Eonguro, Gangnam-gu | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | South Korea |
| Hallym University Sacred Heart Hospital | Pyungchon | Gyunggi-do | South Korea |
| Pusan National University Yangsan Hospital | Mulgeum-eup | Gyungnam | South Korea |
| Samsung Medical Center | Seoul | Ilwon-dong, Kangnam-gu | South Korea |
| Asan Medical Center | Seoul | Pungnap-2-dong, Songpa-gu | South Korea |
| Yonsei University Health System (Sevrance Hospital) | Seoul | Seongsanno, Seodaemun-gu | South Korea |
| Seoul National University Hospital | Seoul | Yeongeon-dong, Chongno-gu | South Korea |
| CS42 and CS42A Safety Analysis Set |
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| CS42 and CS42A Full Analysis Set |
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| CS42A Safety Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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The 156 participants included in the CS42 and CS42A saftey analysis set are included in this baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Degarelix | 80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set). | Posted | Number | Participants | From baseline (day 0) to end of treatment (up to day 364) |
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| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set). | Posted | Number | Participants | From baseline (day 0) to end of treatment (up to day 364) |
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| Secondary | 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). | CS42 and CS42A full analysis set (data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing). The figures present the median of the absolute values at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109). | Posted | Median | Full Range | ng/mL | Day 0, day 196, day 280, and day 364 |
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| Primary | 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. | Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set). | Posted | Number | Participants | From baseline (day 0) to end of treatment (up to day 364) |
|
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From baseline (day 0) to end of treatment (up to day 364)
The investigator monitored the condition of each participant throughout the study from the time the participant signed the informed consent form until the end of study visit or the end of follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Degarelix | 80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals. | 25 | 156 | 88 | 156 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Coronary artery occlusion | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Diabetic retinopathy | Eye disorders | MedDRA (12.0) | Systematic Assessment |
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| Hypermetropia | Eye disorders | MedDRA (12.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Disease progression | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Sudden death | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
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| Drug toxicity | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Metastases to prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
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| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Paraplegia | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Spinal cord compression | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
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| Penile pain | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
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| Perineal pain | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Removal of internal fixation | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
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| Ureteral stent removal | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
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| Title | Measurements |
|---|---|
|
| S-Sodium (mmol/L) <=130 |
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| S-Total bilirubin (micromol/L) >1.5xULN |
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| S-Urea nitrogen (mmol/L) >=10.7 |
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| B-Basophils (%) >=5 |
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| B-Eosinophils (%) >=10 |
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| B-Haematocrit (ratio) <=0.37 |
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| B-Haemoglobin (g/L) <=115 |
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| B-Lymphocytes (%) <=10 |
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| B-Neutrophils (%) >=90 |
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| B-Red blood cell count (10^12/L) <=3.5 |
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| B-White blood cell count (10^9/L) <=2.8 |
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| B-White blood cell count (10^9/L) >=16.0 |
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