NCT01359696已完成1 期
An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine 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
- 40
- 试验地点
- 3
- 主要终点
- Incidence of all adverse events graded according to NCI CTCAE, v4.0
研究概览
简要总结
This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine.
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
- •Age >= 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- •Signed Informed Consent Form
- •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
- •Adequate hematologic and end-organ (liver and kidney) function
- •For female patients of childbearing potential and male patients with partners of childbearing potential, agreement by the patient that the patient and/or partner will use an effective form of contraception
- •Patients enrolled in certain phases must be willing to provide fresh and/or archival tumor samples
排除标准
- •History of prior significant toxicity from a same class of agents as GDC-0425 or gemcitabine requiring discontinuation of treatment
- •Allergy, hypersensitivity or contraindication to the GDC-0425 formulation or gemcitabine
- •Experimental therapy or anti-cancer therapy within 4 weeks prior to the first dose of study drug treatment
- •Radiotherapy within 2 weeks prior to first dose of study drug treatment
- •More than two regimens of cytotoxic chemotherapy for the treatment of locally advanced or metastatic cancer
- •History of receiving high-dose chemotherapy requiring bone marrow or stem cell support
- •History of receiving radiation to more than 25% of bone marrow-bearing areas
- •Acute drug-related toxicities from previous therapies have not resolved prior to study entry, except for alopecia and mild neuropathy
- •Current severe, uncontrolled systemic disease (including but not limited to clinically significant cardiovascular, pulmonary, or renal disease or ongoing or active infection) excluding cancer
- •Significant heart disease and heart dysfunction including but not limited to uncontrolled severe hypertension, heart failure, and reduced cardiac contractility
- •Uncontrolled ascites, due to diseases other than cancer
- •Inability or unwillingness to swallow pills/capsules
- •History of malabsorption or other condition that would interfere with drug absorption
- •Any history of active stomach and/or intestine bleeding within the 6 months prior to screening
- •Known HIV infection
- •Pregnancy, lactation, or breastfeeding
- •Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
- •Inability to comply with study and follow up procedures
研究组 & 干预措施
A
Experimental
干预措施: GDC-0425 (Drug)
A
Experimental
干预措施: gemcitabine (Drug)
结局指标
主要结局
Incidence of all adverse events graded according to NCI CTCAE, v4.0
时间窗: Up to 1 year
Pharmacokinetic property of GDC-0425: determination of plasma drug concentration
时间窗: Up to 12 months or early study discontinuation
Pharmacokinetic property of GDC-0425: exposure
时间窗: Up to 12 months or early study discontinuation
Pharmacokinetic property of GDC-0425: half-life
时间窗: Up to 12 months or early study discontinuation
Severity of all adverse events graded according to NCI CTCAE, v4.0
时间窗: Up to 1 year
Incidence of dose limiting toxicities (DLTs)
时间窗: Up to 35 days
次要结局
- Antitumor activity of GDC-0425 in combination with gemcitabine: determination of tumor response using RECIST v1.1 for patients with measurable disease(Up to 12 months or early study discontinuation)
研究者
研究点 (3)
Loading locations...
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