NCT00003979撤回1 期
Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks
European Organisation for Research and Treatment of Cancer - EORTC56 个研究点 分布在 9 个国家开始时间: 1999年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 56
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 CHS 828 in treating patients who have solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Determine a safe dose of this regimen for phase II evaluation.
- Determine the pharmacokinetic profile of this regimen in these patients.
- Determine any antitumor activity in these patients.
OUTLINE: Patients receive oral CHS 828 every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.
Patients are followed for up to 4 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 not amenable to standard therapy
- •No symptomatic brain or leptomeningeal involvement
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 1.5 mg/dL
- •Other liver function tests no greater than 2 times upper limit of normal (unless related to liver metastases)
- •Creatinine no greater than 1.4 mg/dL
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No active bacterial infection
- •No other nonmalignant disease
- •No alcoholism, drug addiction, or psychiatric disorders
- •Able to take oral medication
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy (6 weeks since extensive radiotherapy)
- •No concurrent radiotherapy (except palliative radiotherapy)
- •Not specified
- •No other concurrent investigational drugs
- •No other concurrent antitumor drugs
排除标准
- 未提供
研究者
研究点 (56)
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