NCT00781846已完成1 期
A Phase I Trial of Oral Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, in Combination With Bevacizumab for Patients With Advanced Cancers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Identification of recommended phase 2 dose of ridaforolimus in combination with bevacizumab
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and recommended phase 2 dose of oral ridaforolimus administered in combination with intravenous bevacizumab in patients with advanced cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •18 years of age or older
- •Advanced or metastatic solid tumor malignancy
- •ECOG performance status of less than or equal to 1
- •Life expectancy of greater than 3 months
- •At least 4 weeks must have elapsed between prior investigational therapy, chemotherapy, or radiotherapy, and the first dose of deforolimus
- •Adequate hematological, hepatic and renal function
- •Serum cholesterol less than or equal to 350 mg/dL and triglycerides less than or equal to 400 mg/dL
- •Signed informed consent
- •Women of childbearing potential must have a negative serum pregnancy test within 7 days of starting therapy and must use an approved contraceptive method from time of screening until 30 days after the last dose of study drug
排除标准
- •Tumor location in close proximity to a major blood vessel
- •History of brain metastases, spinal cord compression, or carcinomatous meningitis. Primary brain tumors (for example, glioblastoma) are allowed.
- •New brain metastases, spinal cord compression, or leptomeningeal metastases on screening CT scan or MRI
- •Hemoptysis or hematemesis within 28 days prior to entering the trial
- •Clinical significant unexplained bleeding within 28 days prior to entering the trial
- •Uncontrolled hypertension
- •Proteinuria at screening
- •Clinically significant cardiovascular disease
- •Newly diagnosed or poorly controlled type 1 or 2 diabetes
- •Active infection requiring prescribed intervention
- •Other concurrent illness that, in the Investigator's judgement, would either compromise the patient's safety or interfere with the evaluation of the safety of the study drug
- •Major surgery within 28 days before trial entry, or any incompletely healed surgical incision; minor surgery or procedures within 7 days
- •Pregnant or breastfeeding
- •Known allergy to macrolide antibiotics
- •Known hypersensitivity to any component of bevacizumab
- •Concurrent treatment with medications that strongly induce or inhibit cytochrome P450 (CYP3A)
- •Known history of HIV sero-positivity
- •Any condition in the Investigator's judgement that renders the patient unable to fully understand and provide informed consent and/or comply with the protocol
研究组 & 干预措施
1
Experimental
30mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks
干预措施: bevacizumab (Drug)
1
Experimental
30mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks
干预措施: ridaforolimus (Drug)
2
Experimental
40mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks
干预措施: ridaforolimus (Drug)
2
Experimental
40mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks
干预措施: bevacizumab (Drug)
3
Experimental
40mg QDx5/wk ridaforolimus plus 15mg/kg Q3wks bevacizumab for 3 weeks
干预措施: ridaforolimus (Drug)
3
Experimental
40mg QDx5/wk ridaforolimus plus 15mg/kg Q3wks bevacizumab for 3 weeks
干预措施: bevacizumab (Drug)
结局指标
主要结局
Identification of recommended phase 2 dose of ridaforolimus in combination with bevacizumab
时间窗: Duration of the trial
次要结局
- Characterize the overall safety and tolerability of ridaforolimus in combination with bevacizumab(Duration of the study)
- Description of the anti-tumor activity of ridaforolimus in combination with bevacizumab(Duration of the study)
研究者
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