EUCTR2009-015628-27-DE进行中（未招募）不适用
A phase Ib/II, multi-center, open-label study to evaluate the efficacy of AUY922 in combination with Trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer, that has progressed after or during at least one Trastuzumab-containing regimen
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Female pts with confirmed HER2-positive, non-operable locally advanced or metastatic breast cancer.
- •All patients must have at least one measurable lesion as defined by
- •RECIST criteria.
- •All patients must have documented progressive disease following the
- •last line of therapy before entering the study
- •ECOG Performance status = 1
- •Other protocol-defined inclusion criteria apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Patients with known CNS metastasis which are symptomatic or require treatment for symptom control and/or growing.
- •Prior treatment with any HSP90 or HDAC inhibitor.
- •Impaired cardiac function
- •Acute or chronic liver or renal disease
- •Patients who are currently receiving treatment with any medication
- •which has a relative risk of prolonging the QTc interval or inducing
- •Torsades de Pointes and cannot be switched or discontinued to an
- •alternative drug prior to commencing AUY922
- •Patients with a history of another primary malignancy that is currently
- •clinically significant or currently requires active intervention
- •Patients who do not have either an archival tumor sample available or
- •are unwilling to have a fresh tumor sample collected at baseline.
- •Other protocol-defined exclusion criteria apply
研究者
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