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Population pharmacokinetic and pharmacodynamic data from Study FE200486 CS06 and FE200486 CS02 provided further knowledge of the optimal dose regimens for FE200486 (degarelix). Both studies were to guide dose selection for phase III. In addition, safety and tolerance data were generated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix 40 mg | Experimental | Degarelix 40 mg (10 mg/mL) |
|
| Degarelix 80 mg | Experimental | Degarelix 80 mg (20 mg/mL) |
|
| Degarelix 120 mg | Experimental | Degarelix 120 mg (30 mg/mL) |
|
| Degarelix 160 mg | Experimental | Degarelix 160 mg (40 mg/mL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug | One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Meet Insufficient Testosterone Response | Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits. | 3 months |
| Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days | The number of participants suppressed for at least 28 days was defined as the estimated "survival probability" at time=Day 28. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Testosterone Castration (Testosterone ≤0.5 ng/mL). | Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. The figures in the table present the number of participants who were castrated after 1, 3, 7, 14, 21, 28, and 42 days. | 1, 3, 7, 14, 21, 28, 42 days |
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Inclusion Criteria:
Each patient must meet the following inclusion criteria before entry into the study:
Exclusion Criteria:
Any patient meeting one or more of the following exclusion criteria will not be entered into the study:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Urology Medical Center | Anaheim | California | 92801 | United States | ||
| South Orange County Medical Research Center |
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The patients were followed until they met a pre-defined criterion for insufficient testosterone or prostate-specific antigen (PSA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Degarelix 40 mg | Degarelix 40 mg (10 mg/mL) |
| FG001 | Degarelix 80 mg | Degarelix 80 mg (20 mg/mL) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Degarelix | Drug | One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection. |
|
|
| Degarelix | Drug | One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection. |
|
|
| Degarelix | Drug | One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection. |
|
|
| Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days | Sufficient testosterone suppression was defined as not meeting an insufficient testosterone response criterion. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits. | 3 months |
| Time to 50% Reduction in Prostate-specific Antigen Levels | The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 50% reduction in PSA level was reached. | 3 months |
| Time to 90% Reduction in Prostate-specific Antigen Levels | The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 90% reduction in PSA level was reached. | 3 months |
| Liver Function Tests | The number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferas levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN. | 3 months |
| Laguna Woods |
| California |
| 92653 |
| United States |
| San Bernardino Urological Associates Medical Group | San Bernardino | California | 92404 | United States |
| Western Clinical Research | Torrance | California | 90505 | United States |
| Urology Associate PC' | Denver | Colorado | 80210 | United States |
| SW Florida Urological Associates | Fort Myers | Florida | 33907 | United States |
| Pinellas Urology, Inc. | St. Petersburg | Florida | 33710 | United States |
| Drs. Werner, Murdock & Francis, PA | Greenbelt | Maryland | 20770 | United States |
| Nevada Urology Associates | Reno | Nevada | 89511 | United States |
| Urology Specialists of Oklahoma, Inc. | Tulsa | Oklahoma | 74104 | United States |
| Urology Clinics of NorthTexas, PA | Dallas | Texas | 75231 | United States |
| Urology San Antonio Research | San Antonio | Texas | 78229 | United States |
| FG002 |
| Degarelix 120 mg |
Degarelix 120 mg (30 mg/mL) |
| FG003 | Degarelix 160 mg | Degarelix 160 mg (40 mg/mL) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Degarelix 40 mg | Degarelix 40 mg (10 mg/mL) |
| BG001 | Degarelix 80 mg | Degarelix 80 mg (20 mg/mL) |
| BG002 | Degarelix 120 mg | Degarelix 120 mg (30 mg/mL) |
| BG003 | Degarelix 160 mg | Degarelix 160 mg (40 mg/mL) |
| BG004 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Gleason score | The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive. | Number | participants |
| |||||||||||||||
| Stage of prostate cancer | Prostate cancer stage was classified to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor. | Number | participants |
| |||||||||||||||
| Body mass index | Body mass index is a measure of body fat based on height and weight. | Mean | Standard Deviation | kilogram per square meter |
| ||||||||||||||
| Serum prostate-specific antigen levels | Median | Full Range | nanogram per milliliter |
| |||||||||||||||
| Serum testosterone levels | Median | Full Range | nanogram per milliliter |
| |||||||||||||||
| Time since prostate cancer diagnosis | The mean number of days since a diagnosis of prostate cancer was made for the patients in each study group. | Mean | Standard Deviation | days |
| ||||||||||||||
| Weight | Mean | Standard Deviation | kilogram |
|
| 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 | Time to Meet Insufficient Testosterone Response | Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits. | Patients who withdrew without meeting the insufficient testosterone (T) suppression criteria were censored as of the time for last available T measurement prior to discontinuation. For the 40 mg group the 95% confidence interval around the time estimate was non-estimable and no statistical analysis is presented (the estimate was 14 days). | Posted | Median | Full Range | days | 3 months |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Testosterone Castration (Testosterone ≤0.5 ng/mL). | Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. The figures in the table present the number of participants who were castrated after 1, 3, 7, 14, 21, 28, and 42 days. | Half participants in the 40 mg group were not castrated and the median was not calculated (no statistical anaylsis was made). Two participants out of 24 in the 80 mg, 1/24 in the 120 mg, and 3/24 in the 160 mg groups were not castrated. For the 160 mg group the 95% CI was non-estimable and no statistical anaylsis was made. | Posted | Number | days | 1, 3, 7, 14, 21, 28, 42 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days | Sufficient testosterone suppression was defined as not meeting an insufficient testosterone response criterion. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits. | Posted | Number | participants | 3 months |
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| Primary | Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days | The number of participants suppressed for at least 28 days was defined as the estimated "survival probability" at time=Day 28. | Posted | Number | participants | 28 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to 50% Reduction in Prostate-specific Antigen Levels | The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 50% reduction in PSA level was reached. | Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only two participants reached a 50% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group). | Posted | Median | Full Range | days | 3 months |
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| Secondary | Time to 90% Reduction in Prostate-specific Antigen Levels | The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 90% reduction in PSA level was reached. | Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only one participant reached a 90% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group). | Posted | Median | Full Range | days | 3 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Liver Function Tests | The number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferas levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN. | Posted | Number | participants | 3 months |
|
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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 40 mg | Degarelix 40 mg (10 mg/mL) | 0 | 6 | ||||
| EG001 | Degarelix 80 mg | Degarelix 80 mg (20 mg/mL) | 1 | 18 | ||||
| EG002 | Degarelix 120 mg | Degarelix 120 mg (30 mg/mL) | 1 | 20 | ||||
| EG003 | Degarelix 160 mg | Degarelix 160 mg (40 mg/mL) | 0 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 4.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 4.1 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 4.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 4.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 4.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 4.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 4.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 4.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 4.1 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 4.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 4.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 4.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
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| Libido decreased | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 4.1 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 4.1 | Systematic Assessment |
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| Urine flow decreased | Renal and urinary disorders | MedDRA 4.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 4.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 4.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 4.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 4.1 | 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.
| 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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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Black |
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| Caucasian |
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| Other |
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| 2-4 |
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| 5-6 |
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| 7-10 |
|
| Locally advanced |
|
| Metastatic |
|
| Not classifiable |
|
| Median days to insufficient T response |
| 84 |
| 95 |
| 35 |
| 112 |
| No |
| Superiority or Other |
| Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response | Median days to insufficient T response | 98 | 95 | 70 | 126 | No | Superiority or Other |
| Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response | Median days to insufficient T response | 35 | 95 | 14 | 98 | No | Superiority or Other |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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