NCT00033566已完成1 期
A Phase I Study of S-3304 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
- 1
研究概览
简要总结
RATIONALE: S-3304 may stop or slow the growth of solid tumors by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of S-3304 in treating patients who have solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and safety profile of S-3304 in patients with advanced solid tumors.
- Determine the pharmacokinetic profile of this drug in these patients.
- Estimate the starting dose of this drug for subsequent phase II efficacy studies.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral S-3304 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 6-8 patients receive escalating doses of S-3304 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose-limiting toxicity.
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 confirmed solid tumor that failed to respond or relapsed after prior therapy or for which no standard therapy exists
- •Biopsy-accessible lesion
- •No brain metastasis unless clinically stable and off therapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 6 weeks
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9.0 g/dL
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •Transaminases less than 2.5 times ULN
- •Creatinine less than 2.0 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 30 days after study
- •Able to tolerate oral medication
- •HIV negative
- •No serious underlying gastrointestinal disorders (e.g., recurrent vomiting or inflammatory bowel disease)
- •No other serious concurrent illness
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy
- •Concurrent stable doses of epoetin alfa are allowed during the second and subsequent courses
- •No other concurrent immunotherapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy:
- •At least 4 weeks since prior hormonal therapy
- •Concurrent stable doses of steroids for prostate cancer are allowed during the second and subsequent courses
- •No concurrent hormonal therapy
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •No prior significant gastric resection
- •Recovered from prior therapy
- •At least 4 weeks since other prior investigational antitumor drugs
- •No other concurrent investigational antitumor drugs
- •Concurrent stable doses of bisphosphonates, cyclo-oxygenase-2 inhibitors, and non-steroidal anti-inflammatory drugs are allowed during the second and subsequent study courses
排除标准
- 未提供
研究者
研究点 (1)
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