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A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese 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 | Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 | Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis. | From Day 28 to Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3 | Proportion of participants with testosterone at castrate level (<= 0.5 ng/mL) at Day 3 | Day 3 |
| Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis | Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% CI was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The FAS analysis results were considered primary, whereas the corresponding PP analysis served as the sensitivity analysis. |
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 |
|---|---|---|---|---|---|---|
| Changhua Christian Hospital | Changhua | Taiwan | ||||
| Chang Gung Medical Foundation, Chiayi Branch |
125 participants were screened and 110 participants were enrolled and exposed to degarelix.
The participants were recruited among the patients attending the clinics included in the trial
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| ID | Title | Description |
|---|---|---|
| FG000 | Degarelix | Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of baseline participants is identical to the number of patients exposed to degarelix.
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| ID | Title | Description |
|---|---|---|
| BG000 | Degarelix | Degarelix 240/80 mg dosing regimen (240 mg is the initiation dose, the 80 mg is the maintenance dose) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 | Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis. | The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset. | Posted | Mean | 95% Confidence Interval | Percentage of participants | From Day 28 to Day 168 |
Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days.
Adverse events were evaluated at each visit.
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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 | Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukaemoid reaction | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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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|
Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28 |
| From Day 0 to Day 28 |
| Cumulative Probability of no PSA Failure | The time to PSA failure was defined as the days from first dosing (scheduled trial days) where an increase in serum PSA of ≥50% from nadir and at least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted. The second occasion was the time point of meeting the criterion. The Kaplan-Meier estimate and associated 95% CI were provided. | Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168 |
| From Day 28 to Day 168 |
| Chiayi City |
| Taiwan |
| Chang Gung Memorial Hospital, Kaohsiung | Kaohsiung City | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | Taiwan |
| China Medical University Hospital | Taichung | Taiwan |
| Taichung Veterans General Hospital | Taichung | Taiwan |
| Chi-Mei Foundation Hospital | Tainan | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Chang Gung Memorial Hospital, Linkuo | Taoyuan | Taiwan |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Degarelix | Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days). |
|
|
| Secondary | Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3 | Proportion of participants with testosterone at castrate level (<= 0.5 ng/mL) at Day 3 | The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset | Posted | Mean | 95% Confidence Interval | Percentage of participants | Day 3 |
|
|
|
| Secondary | Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28 | Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28 | The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset | Posted | Median | Inter-Quartile Range | Percentage change of PSA | From Day 0 to Day 28 |
|
|
|
| Other Pre-specified | Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis | Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% CI was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The FAS analysis results were considered primary, whereas the corresponding PP analysis served as the sensitivity analysis. | The PP analysis set included all participants from the FAS analysis set without major protocol violations. | Posted | Mean | 95% Confidence Interval | Percentage of participants | From Day 28 to Day 168 |
|
|
|
| Secondary | Cumulative Probability of no PSA Failure | The time to PSA failure was defined as the days from first dosing (scheduled trial days) where an increase in serum PSA of ≥50% from nadir and at least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted. The second occasion was the time point of meeting the criterion. The Kaplan-Meier estimate and associated 95% CI were provided. | The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset. | Posted | Mean | 95% Confidence Interval | Percentage of participants | Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168 |
|
|
|
| 9 |
| 110 |
| 69 |
| 110 |
| Acute myocardial infarction | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA (14.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
|
| Carcinoembryonic antigen increased | Investigations | MedDRA (14.0) | Systematic Assessment |
|
| Chest wall mass | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Bladder obstruction | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
|
| Calculus bladder | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
|
| Focal segmental glomerulosclerosis | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
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.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|
| Day 0 to <= Day 112 |
|
| Day 0 to <= Day 140 |
|
| Day 0 to <= Day 168 |
|