NCT00872300终止2 期
An Exploratory Phase II Study of PHA-739358 in Patients With Multiple Myeloma Harbouring the t(4;14) Translocation With or Without FGFR3 Expression
Nerviano Medical Sciences4 个研究点 分布在 2 个国家目标入组 7 人开始时间: 2008年10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
- 7
- 试验地点
- 4
- 主要终点
- Response Rate according to International Myeloma Working Group uniform response criteria for multiple myeloma.
研究概览
简要总结
The purpose of this study is to determine the antitumor activity of PHA-739358 as single agent IV infusion in adult patients with Multiple Myeloma who have a history of at least 2 previous lines of treatment for the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •active multiple myeloma progressing after at least 2 prior lines of treatment
- •measurable disease
- •t(4;14) translocation
- •life expectancy of at least 3 months
排除标准
- •uncontrolled hypertension
- •myocardial infarction, unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the past 6 months.
- •pregnancy or breast feeding
- •active infections, including HIV
研究组 & 干预措施
1
Experimental
干预措施: PHA-739358 (Drug)
结局指标
主要结局
Response Rate according to International Myeloma Working Group uniform response criteria for multiple myeloma.
时间窗: At end of each cycle
次要结局
- Overall safety profile(All cycles)
研究者
研究点 (4)
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相似试验
Unknown
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An Exploratory Phase II Study of PHA-739358 in Patients with Multiple Myeloma Harbouring the t (4;14) translocation with or without FGFR3 ExpressioMultiple Myeloma Harbouring the t (414) translocation with or without FGFR3 ExpressionMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myelomaEUCTR2007-005425-30-FRerviano Medical Sciences S.r.l.20
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不适用
Phase II study of PHA-739358 administered by a 24-hour IV infusion every 14 days in advanced/metastatic breast, ovarian, colorectal, pancreatic, small cell lung and non small cell lung cancers. - not availableProgressive advanced/metastatic breast, ovarian, colorectal, pancreatic, small cell lung and non small cell lung cancers.MedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancerMedDRA version: 9.1Level: LLTClassification code 10057529Term: Ovarian cancer metastaticMedDRA version: 9.1Level: LLTClassification code 10052358Term: Colorectal cancer metastaticMedDRA version: 9.1Level: LLTClassification code 10033610Term: Pancreatic carcinoma metastaticMedDRA version: 9.1Level: LLTClassification code 10059514Term: Small cell lung cancer metastaticMedDRA version: 9.1Level: LLTClassification code 10059515Term: Non-small cell lung cancer metastaticEUCTR2006-003772-35-NLerviano Medical Sciences s.r.l232