NCT01733004已完成1 期
A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Severity and number of adverse events related to escalating doses of MM-141
研究概览
简要总结
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-141 at varying dose levels and frequencies.
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
- •Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy
- •Eighteen years of age or above
- •Able to understand and sign an informed consent (or have a legal representative who is able to do so)
- •Measurable disease according to RECIST v1.1
- •ECOG Performance Score of 0 or 1
- •Adequate bone marrow, hepatic, renal and cardiac function
- •Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-141
排除标准
- •Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
- •Symptomatic CNS disease
- •Received other recent antitumor therapy
- •Pregnant or breast feeding
研究组 & 干预措施
Arm A
Experimental
MM-141 monotherapy
干预措施: MM-141 (Drug)
Arm B
Experimental
MM-141 and Everolimus
干预措施: MM-141 (Drug)
Arm C
Experimental
MM-141 and Abraxane and Gemcitabine
干预措施: MM-141 (Drug)
结局指标
主要结局
Severity and number of adverse events related to escalating doses of MM-141
时间窗: 2 years
Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.
次要结局
未报告次要终点
研究者
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