NCT00191269已完成2 期
A Multicenter Study of LY188011 in Anthracyclines and Taxanes Pre-treated Metastatic/Recurrent Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Tumor Response
研究概览
简要总结
To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with anthracycline and taxane regimen for patients with 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
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically and/or cytologically confirmed breast cancer
- •Received prior chemotherapy for metastatic breast cancer with anthracycline and taxane regimen
- •To have at least one measurable region
- •To have adequate organ function (bone marrow, liver and renal function)
排除标准
- •To have Interstitial pneumonia or pulmonary fibrosis
- •To have inflammatory carcinoma
- •Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
- •To have brain metastasis with symptom
- •To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)
研究组 & 干预措施
A
Experimental
Dose Level 1 - 1000 mg/m2
干预措施: gemcitabine (Drug)
B
Experimental
Dose Level 2 - 1250 mg/m2
干预措施: gemcitabine (Drug)
结局指标
主要结局
Tumor Response
时间窗: baseline to measured progressive disease
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
次要结局
- Duration of Response(time of response to progressive disease)
- Time to Progressive Disease(baseline to measured progressive disease)
- Survival at 1 Year(baseline to date of death from any cause, evaluate at 1 year)
- Pharmacokinetics - Normalized Cmax(cycle 1)
- Pharmacokinetics - Normalized Area Under the Curve(cycle 1)
研究者
研究点 (1)
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