NCT00017524已完成1 期
A Phase I Dose-Escalation Study of AG2037 Administered Once Weekly for Three Weeks to Patients With Advanced Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 3
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of AG2037 in treating patients who have advanced, metastatic, or recurrent solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxic effects of AG2037 in patients with advanced, metastatic, or recurrent solid tumor.
- Determine the safety and tolerance of this drug in these patients.
- Assess the pharmacokinetics of this drug in these patients.
- Document any antitumor effects of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive AG2037 IV weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of AG2037 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed solid tumor
- •Advanced, metastatic, or recurrent disease
- •No curative therapy exists
- •Measurable or evaluable disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •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 (unless due to Gilbert's syndrome)
- •SGOT OR SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance at least 60 mL/min
- •No unstable or severe concurrent medical condition that would preclude study participation
- •No sociological or familial condition that would preclude study compliance
- •No psychological or addictive disorder that would preclude study compliance
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy and recovered
- •No prior radiotherapy to more than 40% of bone marrow
- •Not specified
- •At least 2 weeks since prior blood transfusions
- •At least 4 weeks since prior investigational agent and recovered
- •No prior glycinamide ribonucleotide formyltransferase (GARFT) inhibitor
- •No concurrent extradietary folate supplements
- •No concurrent allopurinol
- •No other concurrent anticancer or investigational agents
排除标准
- 未提供
研究者
研究点 (3)
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