NCT01356173已完成1 期
An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's 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
- 10
- 主要终点
- Incidence of dose limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0349
研究概览
简要总结
This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetic (PK) of GDC-0349 administered once daily (QD), orally (PO).
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 documented, locally advanced or metastatic solid malignancy or NHL without leukemic phase that has progressed or failed to respond to at least one prior regimen and/or are not candidates for regimens known to provide clinical benefit
- •Evaluable or measurable disease per RECIST v1.1 or IWG response criteria for patients with NHL and/or the following: prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels >= 5 ng/mL measured >= 2 weeks apart that meet the PSA, and Working Group criteria for progression prior to initiation of study treatment, and ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN >= 2 weeks apart prior to initiation of study treatment.
- •ECOG performance status of 0 or 1 at screening
- •Life expectancy of >= 12 weeks
- •Adequate hematologic and organ function within 14 days prior to initiation of study treatment
- •Documented willingness to use an effective means of contraception for both men and women while participating in the study and for 90 days after the last dose of GDC-0349
- •Willingness to provide archival tumor tissue
排除标准
- •Leptomeningeal disease as the only manifestation of the current malignancy
- •History of Type 1 or 2 diabetes requiring daily medication
- •Known untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for >= 3 months prior to initiation of study treatment
- •Active congestive heart failure or ventricular arrhythmia requiring medication
- •Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to initiation of study treatment
- •Active infection requiring intravenous (IV) antibiotics
- •Patients requiring any daily supplemental oxygen
- •Uncontrolled hypomagnesemia or hypokalemia
- •Any condition requiring anti-coagulants such as warfarin, heparin, or anti-thrombotics. Prophylactic anti-coagulation and/or local application of thrombolytic agents for catheter patency may be allowed for patients with normal INR and with prior approval from the Medical Monitor
- •Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- •Known human immunodeficiency virus (HIV) infection
- •Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the patients at high risk from treatment complications
- •Significant traumatic injury within 3 weeks prior to initiation of GDC-0349
- •Major surgical procedure within 4 weeks prior to initiation of GDC-0349
- •Treatment with chemotherapy, hormonal therapy (except GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, or radiation therapy (except palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment. Kinase inhibitors, approved by national regulatory authorities, may be used up to 2 weeks prior to initiation of GDC-0349, provided that any drug-related toxicity has completely resolved and prior approval is obtained from the Medical Monitor.
- •Palliative radiation to bony metastases within 2 weeks prior to initiation of GDC-0349
- •Treatment with an investigational agent within 4 weeks prior to initiation of GDC-0349
- •Unresolved toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy
- •Pregnancy or lactation
研究组 & 干预措施
A
Experimental
干预措施: GDC-0349 (Drug)
结局指标
主要结局
Incidence of dose limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0349
时间窗: Up to 30 days
次要结局
- Incidence of adverse events by NCI CTCAE v4.0 grade and associated dose of GDC-0349(Up to 2 years)
- Incidence of Grade 3 and 4 abnormalities in safety related laboratory parameters and associated dose of GDC-0349(Up to 30 days)
研究者
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