NCT00106145已完成1 期
A Phase I Study of MK0752, a Notch Inhibitor, in Patients With Metastatic or Locally Advanced Breast Cancer and Other Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 103
- 主要终点
- Safety and tolerability; MTD will be established
研究概览
简要总结
An investigational study to determine the safety/tolerability, and efficacy of a notch signaling pathway inhibitor in patients with metastatic or locally advanced breast cancer and other advanced solid tumors.
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
- •Women or men greater than or equal to 18 years of age
- •ECOG status less than or equal to 2 (a measurement to determine your ability to perform daily activities)
- •In Parts I, III, and IV, patient must have a histologically confirmed, metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. There is no limit on the number of prior treatment regimens
- •In Part II, only breast cancer patients are eligible
- •In Part V, only patients with Numb negative breast cancer (i.e., tumor shows Numb immunoreactivity in less than 10% of the neoplastic cells assessed) are eligible
- •Patient has recovered from and is at least 2 weeks from previous antineoplastic therapy, including chemotherapy, biological therapy (including Herceptin), hormonal therapy, radiotherapy, or surgery
排除标准
- •Patient has had an investigational treatment in the preceding 21 days
- •Uncontrolled congestive heart failure or myocardial infarction (heart attack) within 3 months of study start
- •History of hepatitis B or C or HIV
- •Patient has the presence of clinically apparent central nervous system metastases or carcinomatous meningitis. Patients with CNS metastases who have completed a course of radiotherapy and are clinically stable in the judgment of the investigator are eligible
- •Patients with "currently active" second malignancy, other than non-melanoma skin cancer, should not be enrolled. Patients are not considered to have a "currently active" malignancy if they have completed therapy for prior malignancy and are considered by their physician to be at <30% risk of relapse
结局指标
主要结局
Safety and tolerability; MTD will be established
时间窗: Day 1 to Day 28
次要结局
- Overall tumor/disease response will be evaluated using RECIST criteria, radiographic and clinical evaluations(radigraphic evaluation = every 56 days)
研究者
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