Everolimus (RAD001) in Combination With Intravenous Carboplatin in Taxane- and Anthracycline-pretreated Patients With Progressive Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Phase I: dose limiting toxicity
研究概览
简要总结
This is an open-label, mono-center phase I/II study designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of RAD001 in combination with carboplatin in taxane- and anthracycline-pretreated patients with progressive metastatic breast cancer. Additionally, the study is designed to characterize the safety, the tolerability and efficacy of this study.
详细描述
During the phase I part the study will include at least 3 patients at each dose-level until MTD is reached. Each cohort will consist of newly enrolled patients. Intra-patient dose escalation is not permitted. Once MTD is reached a total of 6 patients will be treated at MTD (phase I). For the phase II the minimax two-stage design will be applied. After testing the drug on 16 patients in the first stage of phase II, the trial will be terminated if 1 or fewer respond (SD, PR, CR). If the trial goes on to the second stage, a total of 34 patients will be studied during the phase II part.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •adult female patients
- •at least two prior chemotherapies due to metastatic or inoperable breast cancer
- •Karnofsky performance status of at least 60%
- •pretreatment with at least one taxane and one anthracycline
排除标准
- •previous treatment with mTOR-inhibitors, carboplatin, cisplatin or oxaliplatin
- •inadequate organ function including bone marrow function
- •bleeding tumours
- •known uncontrolled metastases in CNS or carcinomatous meningosis
- •patients who have been treated during the last five days with inhibitors or inducers of CYP3A
- •serious pulmonary, neurological, endocrinological or other disorders interfering with this study medication, especially patients with known lung fibrosis, emphysema or severe COPD
结局指标
主要结局
Phase I: dose limiting toxicity
时间窗: after three weeks
Phase II: response rate
时间窗: every six weeks
次要结局
- Phase I: adverse events(after three weeks)