NCT00710268已完成1 期
A Phase I, Open Label, Dual Centre Study To Assess The Safety And Tolerability Of AZD2281 In Combination With Bevacizumab (Avastin®) In Patients With Advanced Solid Tumours
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
- AstraZeneca
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- safety and tolerability of twice daily oral doses of AZD2281 when administered in combination with Bevacizumab to patients with advanced solid tumours by assessment of adverse events, vital signs, ECG, clinical chem, haematology, urinalysis and phys exam
研究概览
简要总结
Phase I, open label, dual centre, dose finding study to evaluate the safety and tolerability of continuous twice daily oral dosing with AZD2281 when administered in combination with Bevacizumab 10mg/kg given every 2 weeks to patients with advanced solid tumours.
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
- •Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent
- •Adequate bone marrow, kidney and liver function in accordance with laboratory parameters set out in the protocol
- •Estimated life expectancy of at least 12 weeks
排除标准
- •Disorders that may put the patient at risk of bleeding, including gastrointestinal perforation, intra-abdominal abcess, major surgery of the chest or abdomen, previous haemorrhage, coughing up blood or thrombotic event
- •Hypertension (high blood pressure) or significant cardiovascular disease
- •Hypersensitivity to Chinese hamster ovary cell products or other recombinant or humanised antibodies
研究组 & 干预措施
1
Experimental
Dose Escalation Study 50, 100, 200, 400 mg
干预措施: AZD2281 (Drug)
1
Experimental
Dose Escalation Study 50, 100, 200, 400 mg
干预措施: Bevacizumab (Drug)
结局指标
主要结局
safety and tolerability of twice daily oral doses of AZD2281 when administered in combination with Bevacizumab to patients with advanced solid tumours by assessment of adverse events, vital signs, ECG, clinical chem, haematology, urinalysis and phys exam
时间窗: various timepoints.
次要结局
- To compare exposure to AZD2281 when given alone and in combination with Bevacizumab, by assessment of appropriate derived PK parameters(various timepoints.)
研究者
研究点 (1)
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