A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886) When Given in Combination With Standard Doses of Selected Chemotherapies to Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 140
- 试验地点
- 5
- 主要终点
- Safety and tolerability of twice daily oral doses of AZD6244 when administered in combination with standard doses of selected chemotherapies.
研究概览
简要总结
This study is being conducted to determine if a combination of AZD6244 given orally twice a day with standard doses of selected chemotherapies will be safe and tolerable for cancer patients with advanced solid tumors. The highest tolerated dose of AZD6244 in combination with selected chemotherapies will be evaluated. The study will also investigate how AZD6244 in combination with standard chemotherapies are absorbed, distributed and excreted by the body as well as the length of time that the drugs remain in the body. Initial and periodic assessments will establish patient response to the combination therapies
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will have measurable and/or non-measurable disease, lacking curative options for whom the selected chemotherapy agents represent the standard of care
- •WHO performance status 0-1
- •Patients must be able to swallow AZD6244 capsules
排除标准
- •Prior treatment with a MEK inhibitor
- •Participation in a clinical study during the last 30 days or have not recovered from side effects of an investigational study drug
- •Brain metastases or spinal cord compression unless treated and stable (for at least 1 month) off steroids
研究组 & 干预措施
1
AZD6244 + docetaxel
干预措施: AZD6244 (Drug)
2
AZD6244 + Dacarbazine
干预措施: AZD6244 (Drug)
3
AZD6244 + Erlotinib
干预措施: AZD6244 (Drug)
1
AZD6244 + docetaxel
干预措施: Docetaxel (Drug)
3
AZD6244 + Erlotinib
干预措施: Erlotinib (Drug)
4
AZD6244 + Temsirolimus
干预措施: AZD6244 (Drug)
4
AZD6244 + Temsirolimus
干预措施: Temsirolimus (Drug)
2
AZD6244 + Dacarbazine
干预措施: Dacarbazine (Drug)
结局指标
主要结局
Safety and tolerability of twice daily oral doses of AZD6244 when administered in combination with standard doses of selected chemotherapies.
时间窗: 28 days +
Incidence and intensity of adverse events as graded by CTCAE (version 3.0), physical examinations, vital signs (including weight, blood pressure and pulse rate), ECG parameters, MUGA scan and echocardiography, clinical chemistry (including liver function tests), Brain Natriuretic Peptide (BNP), Troponin I, hematology, urinalysis, and ophthalmologic examinations.
次要结局
- PK of AZD6244 and selected chemotherapies.(Cycle 1 Day 3 and Cycle 2 day 1)
- Define highest tolerated dose of AZD6244 when in combination with selected chemotherapies.(28 days +)
- Tumor response.(28 days +)