NCT01006785终止2 期
Phase II Clinical Study: A Randomized, Open, and Dose Ranging Study to Evaluate the Efficacy and Safety of DLBS1425 in Subjects With Metastatic / Advanced Breast Cancer
Dexa Medica Group3 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Best overall response rate: proportion of subjects with either complete or partial response according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria at the end of study
研究概览
简要总结
The purposes of this study are :
- to investigate the safety and clinical efficacy of sole therapy with DLBS1425 in suppressing disease-(tumour) progression in subjects with advanced/metastatic breast cancer; and
- to determine the minimal effective and safe dose of DLBS1425 in the therapy of advanced/metastatic breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with Stage IIIB or IV breast cancer who have failed with or refuse to receive standard chemotherapies
- •Subjects with the expression of ER/PR negative; or positive ER/PR expression but have failed with or refuse to receive hormonal therapy
- •Either + or - expression of HER-2/neu gene
- •ECOG status = 0-2
- •At least have 1 evaluable and measurable metastatic lesion as defined by RECIST criteria
- •Adequate haematological, liver, and renal function
- •At least 3 weeks has elapsed since prior chemotherapy, radiotherapy, biological/hormonal therapy
- •At least 4 weeks has elapsed since surgical biopsy / major surgery
排除标准
- •Allergic to the trial product
- •Any other disease state, including infections or uncontrolled illnesses that could interfere with trial participation or trial evaluation
- •Concurrent herbal (alternative) medicine or food supplements suspected to have effect on cancer disease
研究组 & 干预措施
Treatment I
Experimental
DLBS1425 150 mg three times daily
干预措施: DLBS1425 (Drug)
Treatment II
Experimental
DLBS1425 300 mg three times daily
干预措施: DLBS1425 (Drug)
结局指标
主要结局
Best overall response rate: proportion of subjects with either complete or partial response according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria at the end of study
时间窗: 12 -16 weeks
次要结局
- Time point overall response rate(6 weeks)
- Routine hematology(at interval of 2 weeks over the 12 -16 weeks of treatment)
- Liver function(at interval of 2 weeks over the 12 -16 weeks of treatment)
- Renal function(at interval of 2 weeks over the 12 -16 weeks of treatment)
- ECHO(at baseline and at week 6, 12, and 16 of treatment)
- Adverse events(during 12 - 16 weeks of treatment)
研究者
研究点 (3)
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