NCT00060151已完成1 期
A Phase I, Open Label, Multiple Dose, Dose Escalation Study OF GW786034 In Patients With Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Safety and toxicity assessed weekly during treatment
研究概览
简要总结
RATIONALE: GW786034 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and by stopping blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of GW786034 in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the safety and tolerability of GW786034 in patients with advanced solid tumors.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the clinical response in patients treated with this drug.
- Evaluate the effect of this drug on biomarkers of angiogenesis activity in order to estimate activity and to determine the minimum biologically active dose in these patients.
OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study.
Patients receive oral GW786034 twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 2-6 patients receive escalating doses of GW786034 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed advanced solid tumor
- •Refractory to standard therapy or for which no standard therapy exists
- •No untreated leptomeningeal or brain metastases
- •Previously treated brain metastases are allowed if currently asymptomatic and patient is off steroids and antiseizure medications for more than 3 months before study entry
- •PATIENT CHARACTERISTICS:
- •21 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9 g/dL
- •Bilirubin no greater than 1.5 mg/dL
- •AST and ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if tumor involvement)
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular
- •No uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg on 2 consecutive measurements separated by 1 week)
- •No arterial or venous thrombosis (including cerebrovascular accident) within the past 3 months
- •No myocardial infarction within the past 3 months
- •No unstable angina within the past 3 months
- •No cardiac angiopathy or stenting within the past 3 months
- •No cardiac pacemaker
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 21 days after study treatment
- •Able to swallow and retain oral medication
- •Good venous access
- •No prior or concurrent gastrointestinal disease
- •No prior or concurrent condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
- •No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug
- •No other unstable, pre-existing major medical condition
- •No orthopedic pins or rods or other embedded metal that would preclude undergoing an MRI
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 weeks since prior immunotherapy
- •Concurrent epoetin alfa allowed
- •No concurrent anticancer biologic therapy
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •No concurrent anticancer cytotoxic chemotherapy
- •Endocrine therapy
- •See Disease Characteristics
- •More than 4 weeks since prior hormonal or steroid therapy (other than replacement)
- •No concurrent anticancer hormonal therapy (except for replacement)
- •No concurrent dexamethasone or prednisone
- •Radiotherapy
- 另有 20 项未显示
排除标准
- 未提供
结局指标
主要结局
Safety and toxicity assessed weekly during treatment
次要结局
- Disease response every 9 weeks
研究者
研究点 (2)
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