Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer (IM1)
2013年11月18日 更新者：Ferring Pharmaceuticals
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
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer.
研究概览
研究类型
介入性
注册 (实际的)
76
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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British Columbia
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Victoria、British Columbia、加拿大
- Pacific Urologic Research
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Ontario
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Barrie、Ontario、加拿大
- Euroscope Inc
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Brampton、Ontario、加拿大
- Bramalea Medical Centre
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Kitchener、Ontario、加拿大
- Urology Associates/Urologic Medical Research
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North Bay、Ontario、加拿大
- Office of Dr. Bernard Goldfarb
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Quebec
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Greenfield Park、Quebec、加拿大
- Urology South Shore Research
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Alabama
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Homewood、Alabama、美国
- Urology Centers of Alabama
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California
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Laguna Hills、California、美国
- South Orange County Urology Research
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San Bernadino、California、美国
- San Bernadino Urological Association
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Florida
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Aventura、Florida、美国
- South Florida Medical Research
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New York
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Poughkeepsie、New York、美国
- Premier Medical Group of the Hudson Valley
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North Carolina
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Concord、North Carolina、美国
- Carolina Clinical Trials
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South Carolina
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Myrtle Beach、South Carolina、美国
- Carolina Urologic Research Center
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Texas
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Dallas、Texas、美国
- Urology Clinic of North Texas
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San Antonio、Texas、美国
- Urology San Antonio Research, PA
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Degarelix - Cohort 1
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
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实验性的：Degarelix - Cohort 2
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
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实验性的：Degarelix - Cohort 3
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax)
大体时间：Day 0-28 and at Day 112-140
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Day 0-28 and at Day 112-140
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Trough plasma levels (blood sample analysis)
大体时间：Day 28, 56, 84, 112, 140, 168 and 196
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Actual levels prior to dosing
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Day 28, 56, 84, 112, 140, 168 and 196
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of patients with testosterone ≤0.5 ng/mL
大体时间：From baseline to Day 196
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From baseline to Day 196
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Serum levels of testosterone and PSA
大体时间：From baseline to Day 196
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From baseline to Day 196
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Percentage change in PSA levels
大体时间：From baseline to Day 196
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From baseline to Day 196
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Changes in patient-reported injection site pain (VAS scores over time)
大体时间：At 5 minutes and at 60 minutes after each injection
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Will compare starting dose to maintenance doses
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At 5 minutes and at 60 minutes after each injection
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Proportion of patients without clinically significant pain (VAS score of ≤10 mm)
大体时间：60 minutes after each dosing injection
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60 minutes after each dosing injection
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Incidence and severity of investigator-evaluated injection site reactions
大体时间：From baseline to Day 196
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From baseline to Day 196
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Cumulative probabilities of suppressing testosterone to castrate level (≤0.5 ng/mL) by visit
大体时间：From Day 28 onwards (up to Day 196)
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From Day 28 onwards (up to Day 196)
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Predictive one-year suppression rate and 95% CI: The cumulative probability of suppressing testosterone to castrate levels (≤0.5 ng/mL)
大体时间：From Day 28 to Day 364
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From Day 28 to Day 364
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Incidence of adverse events (AEs) examined by frequency, severity, seriousness and discontinuation from study due to AEs
大体时间：From baseline to Day 196
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From baseline to Day 196
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Clinically significant changes in laboratory values
大体时间：From baseline to Day 196
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From baseline to Day 196
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Clinically significant changes in ECGs, vital signs, physical examinations, and body weight
大体时间：From baseline to Day 196
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From baseline to Day 196
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年1月1日
初级完成 (实际的)
2012年11月1日
研究完成 (实际的)
2012年11月1日
研究注册日期
首次提交
2011年11月22日
首先提交符合 QC 标准的
2011年12月12日
首次发布 (估计)
2011年12月14日
研究记录更新
最后更新发布 (估计)
2013年12月12日
上次提交的符合 QC 标准的更新
2013年11月18日
最后验证
2013年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.