NCT00686036终止2 期
A Randomized, Double-blind, Multicentre, Phase II Controlled Trial Assessing ZACTIMATM (Vandetanib) Against Placebo in Prolonging the Off-treatment Interval in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy
Genzyme, a Sanofi Company1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)
研究概览
简要总结
The purpose of this study is to determine whether treatment with Zactima for up to 18 months will prolong the off-treatment interval in patients who are undergoing intermittent androgen deprivation therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of prostate cancer
- •Prostate specific antigen (PSA) greater than or equal to 5 ng/mL
- •Recent completion of first hormone treatment [intermittent androgen deprivation with a Luteinising hormone releasing hormone (LHRH) analogue]
- •Screening PSA ≤1.0 ng/mL (within 6 weeks prior to study Day1)
排除标准
- •Bone or soft tissue metastases
- •Significant cardiovascular disease including hypertension not controlled by medical therapy or history of irregular heart beats or recent heart attack
研究组 & 干预措施
vandetanib
Experimental
300 mg orally, once daily for up to 18 months
干预措施: vandetanib (Drug)
Placebo
Placebo Comparator
orally, once daily for up to 18 months
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)
时间窗: 52 weeks
次要结局
- Percentage of Participants Not Reaching PSA ≥ 5ng/mL and/or PSA 10ng/mL (Biochemical Failure) by 78 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)(78 weeks during off-treatment phase of ADT)
- Serum Testosterone Levels(Change from baseline at each visit post-randomization until until week 78)
- Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL)(From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL)
研究者
研究点 (1)
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