NCT01283048已完成1 期
A Phase I Study of Bevacizumab and Escalation Doses of BKM-120 in Patients With Metastatic Renal Cell Carcinoma Who Failed Prior Systemic Therapies
Toni Choueiri, MD3 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- To determine the maximum tolerated dose and dose limiting toxicities of the combination of BKM-120 and bevacizumab in metastatic renal cell carcinoma
研究概览
简要总结
BKM-120 is a drug that may slow the growth of cancer cells. This drug has been used in laboratory experiments and information from those research studies suggests that this drug may help to slow the growth of renal cancer cells. In this research study, the investigators are testing the safety to BKM-120 at different dose levels. The investigators will also be studying how well tolerated BKM-120 is, and how effective BKM-120 can be in the treatment of kidney cancer.
详细描述
Subjects will receive an intravenous infusion of Avastin on Day 1 and Day 15 of each month (cycle). Subjects will take a daily oral dose of BKM-120 at the dose level assigned.
Subjects will have a clinic visit weekly during Cycle 1 and then on Day 1 and Day 15 of each cycle for blood tests and physical exam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic RCC with clear cell component or papillary RCC
- •Life expectancy > 12 weeks
- •Must have failed at least 1 prior anti-VEGF systemic therapy for metastatic RCC
排除标准
- •Prior treatment with a P13K inhibitor or bevacizumab
- •Untreated brain metastases
- •Acute or chronic liver or pancreatic disease
- •Major mood disorder
- •Concurrent severe and/or uncontrolled medical condition
- •Diabetes mellitus
- •GI disease
- •Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant
- •Pregnant or breastfeeding
- •HIV positive
- •History of another malignancy within 3 years except cured basal cell carcinoma of the skin or excised in situ carcinoma of the cervix
- •Uncontrolled hypertension
研究组 & 干预措施
BKM-120 Bevacizumab
Experimental
BKM-120 60, 80, 100 mg PO QD Bevacizumab 10 mg/Kg every 2 weeks
干预措施: BKM-120 Bevacizumab (Drug)
结局指标
主要结局
To determine the maximum tolerated dose and dose limiting toxicities of the combination of BKM-120 and bevacizumab in metastatic renal cell carcinoma
时间窗: 2 year
次要结局
- To determine additional toxicity and safety information from the combination of BKM-120 and bevacizumab in an expanded cohort of patients at the MTD(2 year)
- To determine the objective response proportion, progression-free survival, overall survival of the combination of BKM-120 and bevacizumab(2 years)
- To determine whether the BKM-120 and bevacizumab combination at the MTD is associated with concomitant changes in angiokines and PI3K pathway members in plasma and tumor samples(2 years)
研究者
Toni Choueiri, MD
Assistant Professor of Medicine
Dana-Farber Cancer Institute
研究点 (3)
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