An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0068 in Patients With Refractory Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- PK parameters after single and multiple doses of GDC-0068
研究概览
简要总结
This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0068 administered to patients with incurable, locally advanced or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy. This study is expected to enroll approximately 39 to 57 patients at approximately two sites in Spain.
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 documented, incurable, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable.
- •Evaluable or measurable disease
- •Life expectancy >= 12 weeks
- •Adequate hematologic and organ function within 14 days before initiation of GDC-0068
- •Documented willingness to use an effective means of contraception (e.g., abstinence, hormonal or double barrier method, surgically sterilized partner) for both men and women while participating in the study
排除标准
- •History of Type 1 or 2 diabetes mellitus requiring regular medication
- •Grade > 2 hypercholesterolemia or hypertriglyceridemia
- •Malabsorption syndrome or other condition that would interfere with enteral absorption
- •Leptomeningeal disease as the only manifestation of the current malignancy
- •Known untreated malignancies of the brain or spinal cord, or treated brain metastases that are not radiographically stable for >= 3 months
研究组 & 干预措施
A
干预措施: GDC-0068 (Drug)
结局指标
主要结局
PK parameters after single and multiple doses of GDC-0068
时间窗: Through study completion or early study discontinuation
Occurrence of adverse events by NCI CTCAE grade and associated dose of GDC-0068
时间窗: Through study completion or early study discontinuation
Occurrence of dose-limiting toxicities (DLTs) by NCI CTCAE grade and associated dose of GDC-0068
时间窗: Through study completion or early study discontinuation
Occurrence of Grade 3 or 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0068
时间窗: Through study completion or early study discontinuation
次要结局
- Best overall response, duration of objective response, and progression-free survival (PFS) for patients with measurable disease according to RECIST(Through study completion or early study discontinuation)