NCT00243347已完成1 期
An Exploratory, Open-Lael Study to Assess the Effects of AZD2171 on Tumors and Biomarkers in Patients With Previously Untreated or Recurrent Non-small Cell Lung Cancer (NSCLC) or Patients With Metastatic or Recurrent Head and Neck Cancer (HNC)
适应症
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
- 19
- 试验地点
- 2
- 主要终点
- Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET)
研究概览
简要总结
This study is to examine the effects on tumors of AZD2171, in the treatment of NSCLC or HNC. The safety and tolerability of AZD2171 will also be studied.
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 or cytologically confirmed head and neck cancer (HNC) or unresectable stage IIIb or IV non-small cell lung cancer (NSCLC)
- •At least one lesion able to be used for tumor biopsy and to be measured by FDG-PET Scan
- •Considered suitable for treatment of NSCLC with no prior biological or immunological therapy for disease
- •Or considered suitable for treatment for metastatic or recurrent HNC with no prior biological or immunological therapy for disease
排除标准
- •NSCLC: Have received more than 2 previous chemotherapy regimens or have received the last chemotherapy or radiotherapy within 28 days of first dose of AZD2171
- •HNC: Previous chemotherapy or radiotherapy if received 28 days of first dose of AZD2171
- •Untreatable, unstable brain or meningeal metastases.
- •Abnormal liver and kidney blood chemistries
- •History of poorly controlled hypertension with resting blood pressure of >150/100
- •Recent (< 14 days) major surgery or a surgical incision not fully healed
- •Diabetes patients with type I insulin dependent diabetes or poorly controlled type II
- •Significant hemorrhage or hemoptysis
- •Presence of necrotic/hemorrhagic tumor or metastases
结局指标
主要结局
Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET)
时间窗: Randomisation until Day 22
Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-\[F-18\]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value - baseline SUVmax value)/baseline SUVmax value)\*100
次要结局
- Change From Baseline in Mean Arterial Blood Pressure (MAP)(Randomisation until Day 22)
研究者
研究点 (2)
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