NCT00975182已完成1 期
A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced 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
- 58
- 主要终点
- Incidence, nature, and severity of adverse events
研究概览
简要总结
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administered in combination with PO erlotinib in patients with advanced solid tumors and patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen.
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
- •Documented locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable (dose-escalation stage only)
- •Documented locally advanced or metastatic NSCLC in patients who have failed at least one prior chemotherapy-based regimen for incurable disease (cohort-expansion stage only)
- •Adequate organ function as assessed by laboratory tests
- •Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
- •Agreement to use an effective form of contraception for the duration of the study
排除标准
- •Any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe prior to first study treatment
- •Prior treatment with PI3K pathway-inhibiting agents (cohort-expansion stage only)
- •History of Grade >= 3 fasting hyperglycemia or diabetes requiring regular medication
- •Current clinically significant and uncontrolled systemic disease (e.g., cardiovascular, pulmonary, or metabolic)
- •History of clinically significant cardiac or pulmonary dysfunction
- •History of malabsorption syndrome or other condition that would interfere with enteral absorption
- •Clinically significant history of liver disease
- •Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
- •Active autoimmune disease and/or need for corticosteroid therapy
- •Known brain metastases that are untreated, symptomatic, or require therapy
- •Pregnancy, lactation, or breastfeeding
研究组 & 干预措施
A
Experimental
干预措施: GDC-0941 (Drug)
A
Experimental
干预措施: erlotinib HCl (Drug)
结局指标
主要结局
Incidence, nature, and severity of adverse events
时间窗: Through study completion or early study discontinuation
Tumor response
时间窗: Assessed at periodic intervals
次要结局
- PK parameters of GDC-0941 (total exposure, and maximum and minimum serum concentrations)(Through study completion or early study discontinuation)
研究者
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