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

Degarelix

Clinical Development Support

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.

Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients

An Open-Label, Multi-Centre, Extension Trial, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients Requiring Androgen Ablation Therapy

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

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.

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.

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).

Ferring Pharmaceuticals Korea, Ltd.

Ferring Pharmaceuticals

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.

80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.

80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals

Age Continuous

Sex: Female, Male

Korea, Republic of

Region of Enrollment

The 156 participants included in the CS42 and CS42A saftey analysis set are included in this baseline analysis population.

S-Alanine aminotransferase (IU/L) >3xULN

S-Cholesterol (mmol/L) >=8.0

S-Potassium (mmol/L) >=5.8

S-Sodium (mmol/L) <=130

S-Total bilirubin (micromol/L) >1.5xULN

S-Urea nitrogen (mmol/L) >=10.7

B-Basophils (%) >=5

B-Eosinophils (%) >=10

B-Haematocrit (ratio) <=0.37

B-Haemoglobin (g/L) <=115

B-Lymphocytes (%) <=10

B-Neutrophils (%) >=90

B-Red blood cell count (10^12/L) <=3.5

B-White blood cell count (10^9/L) <=2.8

B-White blood cell count (10^9/L) >=16.0

Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables

Diastolic blood pressure <=50 and decrease >=15

Diastolic blood pressure >=105 and increase >=15

Systolic blood pressure <=90 and decrease >=20

Systolic blood pressure >=180 and increase >=20

Pulse rate <=50 and decrease >=15

Pulse rate >=120 and increase >=15

Body weight decrease of >=7% from baseline

Body weight increase of >=7% from baseline

Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

Baseline (Day 0)

Day 196

Day 280

Day 364

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).

Spots Global Cancer Trial Database for Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients

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