NCT00099060已完成1 期
A Phase I/II Study of GW572016 in Patients With Recurrent Malignant Glioma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Toxicity for phase I assessed by CTCAE v.3.0 MacDonald criteria
研究概览
简要总结
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of lapatinib and to see how well it works in treating patients with recurrent glioblastoma multiforme.
详细描述
OBJECTIVES:
Phase I
- Determine the maximum tolerated dose and recommended phase II dose of lapatinib in patients with recurrent malignant glioblastoma multiforme who are taking CYP3A4 enzyme-inducing anti-epileptic drugs (EIAEDs).
- Determine the toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
Phase II
- Determine the efficacy of this drug, in terms of objective tumor response rate, in patients who are taking EIAEDs and in those who are not taking EIAEDs.
- Correlate immunohistochemical measures of cellular proteins and receptors from tumor samples with anti-tumor activity of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignant glioblastoma multiforme
- •Recurrent or progressive disease after prior primary treatment with radiotherapy with or without adjuvant chemotherapy
- •Bidimensionally measurable disease on CT scan or MRI with at least one lesion ≥ 1 cm x 1 cm
- •Paraffin embedded tumor sample available
- •Concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) required for phase I of the study
- •Patients in phase II of the study may or may not be receiving EIAEDs
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Cardiovascular
- •LVEF ≥ 50% by echocardiogram or MUGA
- •No myocardial infarction within the past 6 months
- •No congestive heart failure
- •No unstable angina
- •No active cardiomyopathy
- •No cardiac arrhythmia
- •No uncontrolled hypertension
- •No pulmonary disease requiring oxygen
- •No preexisting peripheral neuropathy ≥ grade 3
- •No history of significant neurologic disorder that would preclude study compliance or ability to give informed consent
- •Gastrointestinal
- •No upper gastrointestinal or other conditions that would preclude compliance with oral medication
- •No active peptic ulcer disease
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor
- •No immune deficiency
- •No history of significant psychiatric disorder (e.g., uncontrolled psychotic disorders) that would preclude study compliance or ability to give informed consent
- •No other serious illness or medical condition that would preclude study participation
- •No known hypersensitivity to compounds of similar chemical or biological composition to lapatinib
- •No active uncontrolled or serious infection
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or other hematopoietic growth factors
- •Concurrent hematopoietic growth factors allowed for treatment of acute toxicity (e.g., febrile neutropenia)
- •Chemotherapy
- •See Disease Characteristics
- •No prior chemotherapy for recurrent disease
- •No more than one prior chemotherapy regimen in the adjuvant setting
- 另有 45 项未显示
排除标准
- 未提供
结局指标
主要结局
Toxicity for phase I assessed by CTCAE v.3.0 MacDonald criteria
时间窗: 7 years
Response for phase II
时间窗: 7 years
次要结局
- Correlative studies on archival tissue(7 years)
- Pharmacokinetics(7 years)
研究者
研究点 (6)
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