EUCTR2009-015628-27-GB进行中（未招募）1 期
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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
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
入选标准
- •- Female patients with confirmed HER-2 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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