ACTRN12610000347066已完成2 期
Phase II, open-label trial of lapatinib and vinorelbine in women with previously treated human epidermal growth factor receptor 2 (HER2/neu) positive metastatic breast cancer to assess progression-free survival.
Breast Cancer Research Centre of WA0 个研究点目标入组 19 人开始时间: 2010年4月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Electrocardiogram (ECG) with QTc interval less than or equal to 480 msecs .
排除标准
- •Subjects meeting any of the following History of allergic or hypersensitivity reactions to either study drug (or related compounds) or their excipients.
- •Females who are pregnant or continuing to breast-feed.
- •Subjects who have received more than 2 different types of treatment with a Her2/neu targeted therapy for metastatic breast cancer
- •Evidence of a significant medical illness, abnormal laboratory finding or adverse event from prior anti-cancer therapy that would, in the investigators judgment, make the subject inappropriate for this study .
- •Any serious psychiatric disorder, dementia or altered mental status that would interfere with the subject’s safety or compliance to the study procedures.
- •GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory gastrointestinal (GI) disease (e.g., Crohn’s, ulcerative colitis).
- •Current active hepatic or biliary disease (with exception of subjects with Gilbert’s syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- •Active cardiac disease
- •Concurrent therapy given to treat cancer including treatment with hormonal therapy, an investigational agent or concurrent participation in another clinical trial involving anti-cancer investigational drug.
- •Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
- •Neuropathy = grade 2 at baseline
- •Subjects previously treated with any vinorelbine or capecitabine (other than with lapatinib)
- •Subjects cannot have received any other chemotherapy agent concurrent with trastuzumab and the taxane apart from the inclusion of a platinum agent in the first HER2/neu targeted regimen used in the metastatic setting .
- •Prior treatment with anthracyclines with a cumulative dose of doxorubicin > 400 mg/m2 or epirubicin >800mg /m2 or equivalent dose for other anthracyclines derivatives .
- •Subjects who have concurrent active infections requiring IV antibiotics or non-healing wound.
研究者
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