NCT01226277已完成1 期
An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered Daily in Patients With Refractory Solid Tumors or Lymphoma
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
- 42
- 主要终点
- Changes in vital signs, ECGs, and clinical laboratory results
研究概览
简要总结
This is an open-label, multicenter, Phase I dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics (PK) of GDC-0917 in patients with refractory solid tumors or lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 or cytologically documented, locally advanced or metastatic solid tumors or lymphoma for which standard therapy either does not exist or has proven ineffective or intolerable
- •Life expectancy >/= 12 weeks
- •Adequate hematologic and end organ function
- •For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use an effective form of contraception and to continue its use for the duration of the study.
排除标准
- •Clinically significant history of chronic liver disease, active hepatic infection, evidence of hepatic cirrhosis or Grade >/= 2 liver dysfunction not due to hepatic metastases of cancer, current alcohol abuse, active infections with hepatitis B virus, or hepatitis C virus
- •Grade >/= 2 fever or associated constitutional symptoms, or a clinically significant systemic infection within the last month
- •Autoimmune disease
- •History of clinically significant pulmonary disease
- •Need for chronic and continuous systemic or topical corticosteroids or immunosuppressive therapy within 2 weeks prior to study entry or anticipated need of continuous systemic corticosteroids or immunosuppressive therapy during study participation.
- •Allergy or hypersensitivity to components of the GDC-0917 formulation
- •Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1
- •Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1
- •Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment
- •Prior anti-cancer therapy within 4 weeks before the first dose of study drug treatment in Cycle 1
- •All acute drug-related toxicities must have resolved prior to study entry, except for alopecia and Grade 1 neuropathy
- •Current severe, uncontrolled systemic disease excluding cancer
- •History of clinically significant cardiac dysfunction
- •History of malabsorption or other condition that would interfere with enteral absorption
- •Any history of active GI bleeding within the past 6 months prior to screening
- •Known HIV infection
- •Uncontrolled ascites, due to diseases other than cancer, requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment
- •Pregnancy, lactation, breastfeeding or unwillingness to use birth control during the study and for 3 months after the last dose of GDC-0917
- •Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
研究组 & 干预措施
A
Experimental
干预措施: GDC-0917 (Drug)
结局指标
主要结局
Changes in vital signs, ECGs, and clinical laboratory results
时间窗: Throughout study or until early discontinuation
Incidence and nature of dose-limiting toxicities and adverse events of special interest
时间窗: Throughout study or until early discontinuation
Incidence, nature, and severity of all adverse events and serious adverse events
时间窗: Throughout study or until early discontinuation
次要结局
- Pharmacokinetic parameters of GDC-0917 (including total exposure, maximum and minimum serum concentration, time to maximum observed plasma concentration, elimination of half-life, accumulation at steady-state)(Throughout study or until early discontinuation)
研究者
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