A Phase I Study of GDC-0919 for Adult Patients With Recurrent Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Percentage of patients with dose-limiting toxicities
研究概览
简要总结
This is an open-label Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0919, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 solid tumor that is relapsed/refractory to standard therapies or for which no approved or curative therapy exists
- •Age > or = 18
- •Eastern Cooperative Oncology Group (ECOG) performance status < 2
- •Life expectancy > or = 12 weeks
- •Adequate hematologic and organ function before initiation of GDC-0919
- •For some patients only: Accessible lesions amenable to paired fresh tumor biopsies
排除标准
- •Some prior cancer immunotherapies
- •Untreated brain metastases
- •Active or history of autoimmune disease
研究组 & 干预措施
GDC-0919 Dose Escalation
GDC-0919 to be given on an outpatient basis as a single agent. Starting dose of GDC-0919 will be 50 mg by mouth every 12 hour. Patients will receive the study drug daily for 21 days followed by 7 days off for a cycle length of 28 days; or on 28 consecutive days of a 28-day cycle
干预措施: GDC-0919 (Drug)
结局指标
主要结局
Percentage of patients with dose-limiting toxicities
时间窗: 28 days
Number of dose-limiting toxicities
时间窗: 28 days
Percentage of patients with adverse events
时间窗: approximately 15 months
次要结局
- Pharmacokinetics: Serum concentrations (Cmax/Steady State)(21 days)