An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 12
- 主要终点
- Liver Function Tests
研究概览
简要总结
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.
详细描述
The data include participants from both the main study (FE200486 CS06; NCT00117949) and the extension study FE200486 CS06A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Each patient must meet the following inclusion criteria before entry into the study:
- •Has given written consent before any study related activity is performed. A study related activity is defined as any procedure that would not have been performed during the normal management of the patient.
- •Has had sufficient testosterone suppression (as defined in the withdrawal criteria of FE200486 CS06) for at least 28 days.
排除标准
- •Any patient meeting any of the following exclusion criteria will not be entered into the study:
- •Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen (PSA) suppression as defined in Study FE200486 CS06 in the absence of concomitant rise in testosterone level or non-compliance with protocol required procedures.
- •Requires hormonal therapy for neoadjuvant purposes.
- •Requires treatment with any other drug modifying the testosterone level or function.
- •Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy, within 6 months after Visit
- •Has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions.
- •Has hypersensitivity towards any component of the investigational product.
- •Has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin.
- •Has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study, as judged by the investigator.
- •Any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases and bilirubin must be within normal limits).
- •Has a mental incapacity or language barrier precluding adequate understanding or co-operation.
研究组 & 干预措施
Degarelix 40 mg
Degarelix 40 mg (10 mg/mL)
干预措施: Degarelix (Drug)
Degarelix 80 mg
Degarelix 80 mg (20 mg/mL)
干预措施: Degarelix (Drug)
Degarelix 120 mg
Degarelix 120 mg (30 mg/mL)
干预措施: Degarelix (Drug)
Degarelix 160 mg
Degarelix 160 mg (40 mg/mL)
干预措施: Degarelix (Drug)
结局指标
主要结局
Liver Function Tests
时间窗: 3 years
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.
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
时间窗: 3 years
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.
次要结局
未报告次要终点