A Phase I Study of BAY 43-9006 (Sorafenib) in Combination With OSI-774 (Erlotinib; Tarceva) in Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose and recommended phase II dose
研究概览
简要总结
RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib and erlotinib in treating patients with metastatic or unresectable solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of sorafenib and erlotinib in patients with metastatic or unresectable solid tumors.
Secondary
- Determine the optimal biologically effective dose of this regimen that will lead to hypophosphorylation of epidermal growth factor receptor (EGFR), ERK, Akt, and vascular endothelial growth factor receptor (VEGFR), and inhibition of angiogenesis and apoptosis with tolerable toxicity in these patients.
- Correlate the pharmacokinetic profiles of this regimen with toxicity and biological activity in these patients.
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
- Correlate phosphorylation status of EGFR, ERK, Akt, and VEGFR with antitumor activity of this regimen in these patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
OSI-774 erlotinib) and Bay 43-9006 (Sorafenib)
Sorafenib administered alone for a 1-week run-in period, and then both drugs e given together continuously, with every 28 days considered as a cycle. Three dose levels assessed.
干预措施: erlotinib hydrochloride (Drug)
OSI-774 erlotinib) and Bay 43-9006 (Sorafenib)
Sorafenib administered alone for a 1-week run-in period, and then both drugs e given together continuously, with every 28 days considered as a cycle. Three dose levels assessed.
干预措施: sorafenib tosylate (Drug)
结局指标
主要结局
Maximum tolerated dose and recommended phase II dose
时间窗: 28 days
次要结局
- Pharmacodynamic outcomes(Pre study and cycle 1)
- Correlation of EGFR, AKT, ERK and VEGFR with antitumor activity(If responses or prolonged stable disease are observed)
- EGFR activating mutations, gene amplification status, EGFR intron 1 polymorphism if responses or prolonged disease stabilization are seen(If responses or prolonged stable disease are observed)
- Pharmacokinetic outcomes(Pre-study, cycle 1 and cycle 2)
- Antitumor activity(Every 8 wks)