NCT01547546已完成1 期
An Open-label, Phase I, Dose-escalation Study Evaluating the Safety and Tolerability of GDC-0084 Administered to Patients With Progressive or Recurrent High-grade Glioma
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
- 29
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This open-label, multicenter, Phase I, dose-escalating study will evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy of GDC-0084 in patients with progressive or recurrent high-grade glioma. Stage 1 is the dose escalation part of the study. Stage 2, patients will receive GDC-0084 at a recommended dose for future studies.
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
- •Adult patients, >/= 18 years of age
- •Interval of at least 12 weeks from completion of adjuvant radiotherapy for gliomas to study entry
- •Karnofsky Performance Status of >/= 70 at screening
- •Confirmed measurable disease per RANO
- •Adequate hematologic and organ function
- •Patients enrolled in Stage 1:
- •Histologically documented recurrent or progressive high-grade gliomas (WHO Grade III-IV)
- •Prior treatment with at least one regimen for gliomas (radiotherapy with or without chemotherapy for Grade III gliomas and radiotherapy with chemotherapy for Grade IV gliomas) and/or not considered to be a candidate for regimens known to provide clinical benefit
- •Patients enrolled in Stage 2:
- •Histologically documented recurrent or progressive glioblastoma (WHO Grade IV gliomas)
- •Prior treatment with one or two regimens for glioblastoma (with the initial regimen consisting of radiotherapy with chemotherapy)
排除标准
- •Treatment with anti-tumor therapy (approved or experimental) within 4 weeks prior to initiation of study drug
- •Requirement for anticoagulants such as warfarin or any other warfarin-derivative anticoagulants; low-molecular-weight heparin is permitted
- •Any contraindication to MRI examination
- •Evidence of Grade >/= 1 intracranial hemorrhage
- •Active congestive heart failure or ventricular arrhythmia requiring medication
- •Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse or cirrhosis
- •Unresolved toxicity from prior therapy with the exception of lymphopenia (for patients with prior temozolomide) and alopecia
- •Pregnant or lactating women
研究组 & 干预措施
Single Arm
Experimental
干预措施: GDC-0084 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: approximately 1 year
Safety: Incidence of adverse events
时间窗: approximately 2 years
次要结局
- Duration of response(approximately 2 years)
- Pharmacokinetics: Area under the concentration-time curve(Pre- and post-dose Days 1, 8, 15, 22 and 29 Cycle 1, Day 1 every following Cycle until 30 days after the last dose of study drug)
- Best overall response rate, tumor assessments according to Response Assessment in Neuro-Oncology (RANO)(approximately 2 years)
- Progression-free survival(approximately 2 years)
研究者
相似试验
已完成
1 期
A Study of GDC-0575 Alone and in Combination With Gemcitabine in Participants With Refractory Solid Tumors or LymphomaLymphoma, Solid TumorNCT01564251Genentech, Inc.104
已完成
1 期
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or LymphomaSolid TumorNCT01359696Genentech, Inc.40
已完成
1 期
Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's LymphomaNon-Hodgkin's Lymphoma, Solid TumorNCT01356173Genentech, Inc.10
已完成
1 期
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0623 in Patients With Locally Advanced or Metastatic Solid TumorsSolid CancersNCT01106599Genentech, Inc.61
已完成
1 期
A Study of GDC-0941 in Participants With Locally Advanced or Metastatic Solid Tumors for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or IntolerableSolid CancersNCT00876109Genentech, Inc.108