NCT00609011已完成1 期
Dose Finding Phase 1 Study of the Treatment of Metastatic Melanoma With MPC-6827 in Combination With Temozolomide
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Myrexis Inc.
- 入组人数
- 22
- 试验地点
- 10
- 主要终点
- Safety and Tolerability; Maximum Tolerated Dose
研究概览
简要总结
This is an open-label, dose finding, multiple-dose study in subjects with metastatic melanoma. Three dose levels of MPC-6827 will be administered with temozolomide to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, determination of dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with temozolomide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically proven melanoma
- •For subjects with brain metastases that require radiation, therapy must have been completed at least 4 weeks prior to Day 1 of Study Drug
- •Have unresectable melanoma with measurable metastases
- •Be a minimum of 4 weeks since prior surgical resection or major surgical procedure and a minimum of 2 weeks since chemotherapy/ biochemotherapy
- •Performance score of Karnofsky ≥ 60%, or Eastern Cooperative Oncology Group (ECOG) ≤ 2, or WHO ≤ 2
- •If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week
排除标准
- •Hypersensitivity to Cremophor EL
- •Have current/active intratumor hemorrhage by CT/MRI within 3 weeks prior to Day 1 of Study Drug confirmed by CT/MRI
- •Have ocular melanoma
- •Have primary intradural melanoma or leptomeningeal involvement
- •Have cardiovascular disease (unstable angina or MI)
- •Have cerebrovascular disease (stroke and/or TIA)
- •Have uncontrolled hypertension
- •Have a cardiac ejection fraction < 50%
- •Have Troponin-I elevated above the normal range
结局指标
主要结局
Safety and Tolerability; Maximum Tolerated Dose
时间窗: After each cohort is enrolled
次要结局
- Antitumor Activity(Screening, end of each cycle, end of study)
- Pharmacokinetics(Cycle 1)
研究者
研究点 (10)
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