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

Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity to continue treatment with degarelix under a clinical study until FE200486 was available on the market or until the study was discontinued.

Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of FE200486.

The data include participants from both the main study (FE200486 CS06; NCT00117949) and the extension study FE200486 CS06A.

Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase 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.

Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.

Ferring Pharmaceuticals

Degarelix 40 mg

Degarelix 80 mg

Degarelix 120 mg

Degarelix 160 mg

Total

Age, Categorical

Age Continuous

Sex: Female, Male

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

Body mass index

Mean number of days since the participants in each treatment were diagnosed with prostate cancer.

Time since prostate cancer diagnosis

Weight

Abnormal alanine aminotransferase (ALAT)

Abnormal aspartate aminotransferase

Abnormal bilirubin

ALAT >3x ULN

ALAT >3x ULN, bilirubin >1.5x ULN

The data include patients from both the main study (FE200486 CS06) and the extension study FE200486 CS06A.

Liver Function Tests

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

Heart rate <=50 and decrease >=15

Heart rate >=120 and increase >=15

Body weight decrease of >=7 percent

Body weight increase of >=7 percent

These data include patients from the main study (FE200486 CS06) and the extension study (FE200486 CS06A).

Participants With Markedly Abnormal Change in Vital Signs and Body Weight

Overall Study

Spots Global Cancer Trial Database for Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial