NCT02726009已完成4 期
An Open-label, Single-Arm, Multicenter, Phase IV Trial to Evaluate the Safety of Firmagon® in Androgen Deprivation Therapy in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 19
- 主要终点
- Frequency of adverse events
研究概览
简要总结
The purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced hormone-dependent prostate cancer requiring androgen deprivation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Has given written informed consent before any study-related activity is performed
- •Advanced hormone-dependent prostate cancer for which androgen deprivation therapy is indicated, and independently from this trial, Firmagon® is intended to be used for treatment
- •Age greater than or equal to 18 years and less than 80 years
- •Advanced hormone-dependent prostate cancer without any other clinically significant disorder
- •Easten Cooperative Oncology Group score ≤ 2
- •PSA ≥ 2 ng/mL at screening
- •Life expectancy of at least 12 months as per the investigator's judgement
排除标准
- •Previous or concurrent hormonal management of prostate cancer
- •Contraindication for prescription of Firmagon®
- •Concurrent treatment with a 5-α-reductase inhibitor
- •Considered as a candidate for curative therapy
- •History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
- •QTc interval over 450 msec or risk factors for torsades de pointes or on Class IA and Class III anti arrhythmic medications
- •Cancer within the last 5 years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
- •Known or suspected hepatic, symptomatic biliary disease (this includes moderate to severe chronic hepatic impairment)
- •Patients with clinically significant laboratory abnormalities / disorders other than prostate cancer
- •Patient with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) infections
研究组 & 干预措施
Degarelix
Experimental
干预措施: Degarelix (Drug)
结局指标
主要结局
Frequency of adverse events
时间窗: Up to Day 364
Severity of adverse events
时间窗: Up to Day 364
Clinically significant changes in laboratory values (hematology and clinical biochemistry)
时间窗: From baseline to Day 364
Clinically significant changes in vital signs
时间窗: From baseline to Day 364
次要结局
- Change in International Prostate Symptom Score (IPSS)(From baseline to Day 364)
- Change in physician's satisfaction score(From baseline to Day 364)
- Cumulative probability of no Prostate Specific Antigen (PSA) failure(Up to Day 364)
- Cumulative probability of Progression Free Survival (PFS)(Up to Day 364)
研究者
研究点 (19)
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