Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.

Degarelix

One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.

One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.

One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.

Clinical Development Support

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.

Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

An Open-Label, Multi-Center, Ascending, Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

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.

The number of participants suppressed for at least 28 days was defined as the estimated "survival probability" at time=Day 28.

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.

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.

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.

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.

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.

Ferring Pharmaceuticals

Degarelix 40 mg

Degarelix 80 mg

Degarelix 120 mg

Degarelix 160 mg

Total

Age, Categorical

Age Continuous

Sex: Female, Male

Oriental/Asian

Black

Caucasian

Other

Race/Ethnicity, Customized

Unknown

7-10

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.

Gleason score

Localized

Locally advanced

Metastatic

Not classifiable

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.

Stage of prostate cancer

Body mass index is a measure of body fat based on height and weight.

Body mass index

Serum prostate-specific antigen levels

Serum testosterone levels

The mean number of days since a diagnosis of prostate cancer was made for the patients in each study group.

Time since prostate cancer diagnosis

Weight

Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response.

Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response

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).

Time to Meet Insufficient Testosterone Response

Kaplan-Meier estimates of the median time to testosterone castration.

Kaplan-Meier estimates of the time to testosterone castration.

1 day

3 days

7 days

14 days

21 days

28 days

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.

Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).

Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.

Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days

Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.

Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days

Kaplan-Meier estimates of the time (days) to 50% reduction in PSA

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).

Time to 50% Reduction in Prostate-specific Antigen Levels

Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.

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).

Spots Global Cancer Trial Database for Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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