NCT00292864已完成1 期
Phase 1 Open-Label, Multicenter, Dose-Escalation Clinical Study of the Safety and Tolerability of SNS-032, a Novel Cyclin-Dependent Kinase Inhibitor, Administered to Patients With Select Advanced Solid Tumors
Sunesis Pharmaceuticals12 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2006年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 12
- 主要终点
- Tolerability
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of one-hour infusions given once daily for 5 consecutive days in a 21-day treatment cycle; to define a recommended phase 2 dose; and to learn more about the clinical activity of SNS-032.
详细描述
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body), preliminary evaluation of biomarkers to see how the levels of certain proteins change after administration of SNS-032; assessment of the effects of SNS-032 on QT interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Able to provide written informed consent
- •Advanced, progressing solid tumor that has no cure
- •In Stage 1, any advanced solid malignancy
- •In Stage 2, advanced breast cancer, melanoma, or non-small cell lung cancer (NSCLC)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
- •Recovered from radiation therapy that may have been given in the last 21 days
- •Recovered from surgery
排除标准
- •Prior exposure to SNS-032 (previously known as BMS-387032)
- •Pregnant or breastfeeding
- •Women or male partners of women who are able to have children but are unwilling to use an approved, effective means of birth control
- •Took part in another clinical trial during the last 21 days
- •Abnormal lab values for serum potassium, hemoglobin, neutrophils, platelets, creatinine, AST, ALT, or total bilirubin
- •Brain metastases, if patient is not neurologically stable or has needed corticosteroids or anticonvulsants at anytime within the 28 day period before enrollment.
- •Other active malignancies
- •Prior pelvic radiation therapy to ≥ 25% of bone marrow reserve
- •Any other condition that would keep the patient from safely taking part in the clinical trial
- •Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if all study criteria are met.
结局指标
主要结局
Tolerability
Safety
次要结局
- Pharmacokinetic profile
- Effect on QT interval
- Potential biomarkers
- Anti-tumor activity
研究者
研究点 (12)
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