NCT01491971已完成2 期
Open-label, Multi-centre, Parallel Group Dose-Escalation Trial Assessing the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 15
- 主要终点
- Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax)
研究概览
简要总结
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer.
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
- •Has a histologically confirmed adenocarcinoma of the prostate, for which endocrine therapy is indicated
- •Has a current tumour, nodule and metastasis (TNM) staging within 12 weeks prior to treatment start and, if clinically indicated a bone scan
- •Has a PSA level meeting one of these criteria:
- •For treatment-naïve patients: Screening PSA level should be ≥2 ng/mL.
- •For patients with recurrence after radical prostatectomy: Patients should have a serum PSA increase of ≥0.2 ng/mL from the previous test on two consecutive measurements
- •For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir
- •Has a screening serum testosterone level above the lower limit of normal range in an elderly male population, globally defined as >150 ng/dL
- •Has an Eastern Cooperative Oncology Group score of ≤2
- •Has a life expectancy of at least one year
排除标准
- •Has had previous or is currently under hormonal management of prostate cancer
- •Is considered to be a candidate for curative therapy i.e. radical prostatectomy or radiotherapy during the trial period
- •Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- •Has a marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval >450 ms)
- •Has a history of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome)
- •Has a previous history or presence of another malignancy, other than prostate
- •Currently receiving chronic treatment with intramuscular medication injected into the ventrogluteal or dorsogluteal muscle
- •Has received an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial
研究组 & 干预措施
Degarelix - Cohort 3
Experimental
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
干预措施: Degarelix (Drug)
Degarelix - Cohort 2
Experimental
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
干预措施: Degarelix (Drug)
Degarelix - Cohort 1
Experimental
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
干预措施: Degarelix (Drug)
结局指标
主要结局
Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax)
时间窗: Day 0-28 and at Day 112-140
Trough plasma levels (blood sample analysis)
时间窗: Day 28, 56, 84, 112, 140, 168 and 196
Actual levels prior to dosing
次要结局
- Proportion of patients with testosterone ≤0.5 ng/mL(From baseline to Day 196)
- Serum levels of testosterone and PSA(From baseline to Day 196)
- Percentage change in PSA levels(From baseline to Day 196)
- Changes in patient-reported injection site pain (VAS scores over time)(At 5 minutes and at 60 minutes after each injection)
- Proportion of patients without clinically significant pain (VAS score of ≤10 mm)(60 minutes after each dosing injection)
- Incidence and severity of investigator-evaluated injection site reactions(From baseline to Day 196)
- Cumulative probabilities of suppressing testosterone to castrate level (≤0.5 ng/mL) by visit(From Day 28 onwards (up to Day 196))
- Predictive one-year suppression rate and 95% CI: The cumulative probability of suppressing testosterone to castrate levels (≤0.5 ng/mL)(From Day 28 to Day 364)
- Incidence of adverse events (AEs) examined by frequency, severity, seriousness and discontinuation from study due to AEs(From baseline to Day 196)
- Clinically significant changes in laboratory values(From baseline to Day 196)
- Clinically significant changes in ECGs, vital signs, physical examinations, and body weight(From baseline to Day 196)
研究者
研究点 (15)
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