CTRI/2009/091/000146Other3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Oral Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) in Patients With Advanced Malignant Pleural Mesothelioma Previously Treated With Systemic Chemotherapy
Merck and Co Inc US6 个研究点 分布在 1 个国家目标入组 660 人开始时间: 2010年3月18日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 660
- 试验地点
- 6
- 主要终点
- Overall survival and safety/toxicity of Vorinostat in this population. Treatment will continue until disease progression or unacceptable toxicity.
研究概览
简要总结
The study was discontinued in India due to slow enrollment. Please note that only one patient was randomized into the study at GCRI Ahmadabad. The patient took the last medication ( discontinued ) on 14 June 2010 . The last site in India was closed on 9th August 2011 & DCGI was informed of the study close out on 7th September 2011.
研究设计
- 研究类型
- Interventional
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient must be 18 years or older with confirmed diagnosis of malignant pleural mesothelioma Patient must have failed prior chemotherapy that included pemetrexed, if available, with either cisplatin or carboplatin Patient must have adequate bone marrow, liver and kidney function Patient must be capable of self-care and out of bed for more than 50% of waking hours Patient must have ability to swallow pills.
排除标准
- •Patient has been treated with other investigational agent that has similar properties Patient has an active infection within 2 weeks of the start of study drug, or had treatment with intravenous antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drug Patient is pregnant or breast feeding.
结局指标
主要结局
Overall survival and safety/toxicity of Vorinostat in this population. Treatment will continue until disease progression or unacceptable toxicity.
时间窗: Time Frame: Throughout study
次要结局
- Progression-free survival, Overall objective response rate, dyspnea score on LCSS-Meso scale, and Forced Vital Capacity change. Treatment will continue until disease progression or unacceptable toxicity(Time Frame: Throughout study)
研究者
研究点 (6)
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