A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 For Metastatic Breast Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 主要终点
- Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)
研究概览
简要总结
BZL 101 is an aqueous extract from herba Scutellaria Barbata D. Don of the Lamiaceae family. Preclinical studies suggest that this herb has antitumor activity for breast cancer and preliminary clinical data suggest that it is tolerable in patients with metastatic breast cancer. The overall goals of this Phase I/II trial are to assess the toxicity, maximum tolerated dose, safety and preliminary efficacy of BZL101 for the treatment of advanced metastatic breast cancer.
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
- •Women 18 years or older
- •Histologically confirmed breast cancer
- •Clinical evidence of metastatic (stage IV) metastasis (other than bone metastasis)
- •Availability of estrogen and progesterone receptor status
- •At least one measurable disease site defined by RECIST criteria, 30 days prior to study therapy
- •For the phase 1, no more that 3 prior cytotoxic regimens for metastatic breast cancer. For the phase 2, no more than 2 prior cytotoxic regimens for metastatic breast cancer
- •Life expectancy ≥ 12 weeks
- •Eastern Cooperative Oncology Group performance status ≤2
- •Women of child bearing potential must agree to 2 forms of contraception during the course of the trial.
排除标准
- •Inability to understand/unwillingness to sign a written informed consent
- •Any significant side effects related to prior chemo, radiation, biology or hormonal therapy that did not resolve in the judgment of the investigator
- •Currently using an investigational agent
- •Clinically significant gastrointestinal abnormalities
- •Currently using coumadin at therapeutic doses or within 2 weeks of taking study medication
- •Concurrent palliative radiation or anti-cancer treatment
- •Women who report pregnancy, are breast-feeding or have a positive pregnancy test
结局指标
主要结局
Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)
时间窗: Monthly
Dose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
时间窗: 2 months
Best Overall Tumor Response - Independent Radiology Assessment
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
时间窗: 2 Months
Best Overall Tumor Response - Investigator Assessment
次要结局
未报告次要终点