NCT01011530已完成1 期
A Phase I, Open-Label, Dose Escalation Study of MLN4924, a Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients With Melanoma
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
- 37
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) and inform recommended phase 2 dose of MLN4924
研究概览
简要总结
This is an open-label, multicenter, phase 1, dose escalation study that will evaluate the safety profile, establish Maximum Tolerated Dose (MTD), and inform the recommended phase 2 dose of MLN4924 as well as evaluate antitumor activity in patients with metastatic melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Each patient must meet all of the following criteria to be enrolled in the study:
- •Diagnosis of metastatic melanoma
- •Measurable disease
- •Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse
- •Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
- •Willing and able to give written informed consent
- •Suitable venous access for study-required blood sampling
- •Appropriate functional status, including the recovery from the effects of prior antineoplastic therapy, and acceptable organ function as described in the protocol
排除标准
- •Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- •Major surgery or, serious infections, or infections that required systematic antibiotic therapy within 14 days before the first dose of study drug
- •Systemic antineoplastic or radiation therapy within 14 days or treatment with any investigational products within 21 days before the first dose of study treatment
- •CYP3A inducers within 14 days of study treatment. Moderate and strong CYP3A inhibitors and CYP3A inducers are not permitted during the study
- •No prior history of amiodarone in the 6 months before the first dose of MLN4924
- •Diarrhea that is greater than Grade 1 as outlined in the protocol
- •Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months
- •Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
- •Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
- •Other clinical and laboratory assessments that do not meet the criteria specified in the protocol
研究组 & 干预措施
MLN4924
Experimental
MLN4924 via IV infusion
干预措施: MLN4924 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) and inform recommended phase 2 dose of MLN4924
时间窗: Up to 12 months of treatment
次要结局
- Pharmacodynamic effects of MLN4924 on blood and tumor cells(Primarily assessed during the first cycle of therapy)
- Anti-tumor activities of MLN4924(Up to 12 months of treatment)
研究者
研究点 (1)
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