Phase I Study of mTOR Inhibitor RAD001 in Combination With IGF-1R Inhibitor AMG479 for Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- To determine the maximum tolerated (MTD) and recommended Phase II doses for AMG479 and RAD001 in patients with refractory solid tumors
研究概览
简要总结
The purpose of this study is to test the safety of the combination of two drugs called RAD001 and AMG479. This study will see what effects (good and bad) RAD001 and AMG479 have on cancer. This study will also find the highest doses of RAD001 and AMG479 that can be given without causing severe side effects.
详细描述
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated (MTD) and recommended Phase II doses for AMG479 (ganitumab) and RAD001 (everolimus) in patients with refractory solid tumors.
II. To determine the safety and toxicity of AMG479 and RAD001.
SECONDARY OBJECTIVES:
I. To determine preliminary antitumor efficacy of AMG479 and RAD001 in solid tumors: response and stable disease rates, duration of response and of stable disease, time to progression (TTP) and overall survival (OS).
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
- •Histological or cytological proof of metastatic solid tumor refractory to standard therapies, or for which no standard therapies are available.
- •Patients in the expansion cohort must have a measurable site of disease according to RECIST (v 1.0)
- •Laboratory values must be obtained within protocol limits and obtained within 14 days prior to registration
- •Patients must have disease which is not amenable to potentially curative surgical resection of metastatic disease (curative metastasectomy).
- •Must be willing to provide metastatic tissue biopsy samples (may be paraffin embedded) at baseline
- •Must be willing to undergo a metastatic tissue biopsy after 2 cycles of therapy to perform pharmacodynamic research biomarkers testing.
- •Subjects must be willing and able to abstain from using strong or moderate CYP3A4 inhibitors or inducers during the study period.
排除标准
- •No symptomatic brain metastasis
- •No prior treatment with an mTOR inhibitor or with an IGF-1R inhibitor
- •No known history of diabetes mellitus
- •No thrombosis or vascular ischemic events within the last twelve months
- •No chronic treatment with systemic steroids or another immunosuppressive agent
- •No active bleeding or a pathological condition that is associated with a high risk of bleeding
- •No known history of HIV seropositivity
- •No known history of Hepatitis B or Hepatitis C seropositivity
- •No known hypersensitivity to AMG 479, RAD001 (everolimus), other rapamycins (sirolimus, temsirolimus), or to its excipients
- •No planned immunization with attenuated live viruses during the study period
研究组 & 干预措施
Open Label
RAD001+ AMG479
干预措施: RAD001 + AMG479 (Drug)
结局指标
主要结局
To determine the maximum tolerated (MTD) and recommended Phase II doses for AMG479 and RAD001 in patients with refractory solid tumors
时间窗: 1 year
To evaluate the grade and severity of adverse events as a measure of safety and toxicity
时间窗: 2 years
次要结局
- To determine preliminary antitumor efficacy of AMG479 and RAD001 in solid tumors(5-10 years)
研究者
Shadia Jalal
Assistant Professor of Medicine
Indiana University School of Medicine