NCT00088647终止1 期
A Phase 1 Dose-Escalation Study of Intravenous MST-997 Formulated in Intralipid 20% Administered Weekly in Subjects With Advanced Malignant Solid Tumors
Wyeth is now a wholly owned subsidiary of Pfizer3 个研究点 分布在 1 个国家开始时间: 2004年8月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 试验地点
- 3
- 主要终点
- To evaluate the safety, tolerability and MTD of IV MST-997 throughout patients participation on trial.
研究概览
简要总结
The primary objective of this clinical research study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of intravenous (IV) MST-997 formulated in Intralipid 20% administered on a weekly schedule to subjects with advanced malignant solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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
- •Documented histological or cytological diagnosis confirming the presence of malignant solid tumor
- •Tumor progression after conventional therapy for cancer or a malignant solid tumor for which no conventional therapy exists
- •Subjects enrolled in the MTD confirmation cohort should have a documented histologic and/or cytologic diagnosis of metastatic breast cancer or non-small cell lung cancer (NSCLC) and should not have received more than 2 prior chemotherapy regimens for metastatic disease (adjuvant and neoadjuvant chemotherapy will not be included in the maximum of 2 prior regimens described above)
排除标准
- •Subjects with symptomatic or clinically active central nervous system (CNS) metastases. Subjects who have had prior treatment with radiotherapy or surgical resection for CNS metastases will be permitted if CNS metastases have remained stable and have not required any treatment for at least 3 months prior to first dose of test article
- •History of any other primary malignancy with less than 5 years documentation of a disease-free state (Subjects with a history of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ, which have been successfully treated, are not excluded)
- •Recent major surgery (within 14 days before the first dose) or chemotherapy within 28 days before the first dose of MST-997 (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
结局指标
主要结局
To evaluate the safety, tolerability and MTD of IV MST-997 throughout patients participation on trial.
次要结局
- To obtain preliminary information on the pharmacokinetics (during cycle 1) and antitumor activity of MST-997 (approximately every 8 weeks).
研究者
研究点 (3)
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