NCT01075464已完成1 期
A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MEGF0444A, a Human IgG1 Antibody, in Combination With Bevacizumab and Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors
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
- 64
- 主要终点
- Incidence, nature, and severity of adverse events
研究概览
简要总结
This is a Phase Ib, open-label, dose-escalation study of MEGF0444A in combination with bevacizumab, and in combination with bevacizumab and paclitaxel as therapy for locally advanced or metastatic solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on or failed to respond to regimens or therapies known to provide clinical benefit
- •Specific to Arm A:
- •For patients undergoing optional or mandatory exploratory MRI, at least one tumor lesion that represents a liver, fixed peritoneal, neck, extremity, or pelvic lesion measuring >/= 3 to 10 cm (for liver lesions) or >= 2 to 10 cm (for all other lesion locations) to be used for MRI
- •Specific to Arm B:
- •Maximum of two prior chemotherapy regimens for metastatic disease
排除标准
- •Anti-cancer therapy within 3 weeks prior to initiation of study treatment
- •Patients who had to discontinue prior bevacizumab therapy due to intolerable toxicity
- •Leptomeningeal disease
- •Active infection or autoimmune disease
- •Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
- •Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases
- •Inadequately controlled hypertension; history of hypertensive crisis or encephalopathy; congestive heart failure (New York Heart Association Class II or greater); history of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment
- •History of hemoptysis; evidence of bleeding diathesis or significant coagulopathy
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment
- •Serious, non-healing wound, active gastrointestinal ulcer, or untreated bone fracture
- •Specific to Arm B:
- •Known significant hypersensitivity to paclitaxel or other drugs using the vehicle cremophor
- •Previous intolerance to paclitaxel
- •Grade >= 2 sensory neuropathy
研究组 & 干预措施
A
Experimental
干预措施: MEGF0444A (Drug)
A
Experimental
干预措施: bevacizumab (Drug)
B
Experimental
干预措施: MEGF0444A (Drug)
B
Experimental
干预措施: bevacizumab (Drug)
B
Experimental
干预措施: paclitaxel (Drug)
结局指标
主要结局
Incidence, nature, and severity of adverse events
时间窗: Until 90 days after last dose of study treatment
Incidence and nature of dose-limiting toxicities (DLTs)
时间窗: Days 1 to 28 of Cycle 1
次要结局
- Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution(Following administration of study drug)
研究者
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