ACTRN12621001419853招募中1 期
A Phase 1 Dose Escalation and Dose Expansion Open-label, Multicenter, Study of OP-1250 in Combination with the CDK4/6 Inhibitor Palbociclib in Adult Subjects with Advanced or Metastatic HR-positive, HER2-negative Breast Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
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
- All
入选标准
- •1. Hormone receptor-positive (HR+)/ human epidermal growth factor receptor 2-negative (HER2-) disease, as determined in the most recently obtained archival tumor tissue sample from a metastatic site, using locally accepted criteria by the local pathology report.
- •2. Willing and able to participate and comply with all study requirements and to provide signed and dated informed consent prior to initiation of any study procedures.
- •3. Histologically- or cytologically-confirmed locally advanced or MBC for which standard curative measures do not exist.
- •4. Life expectancy more than 6 months, as judged by the Investigator.
排除标准
- •1. Prior or concurrent malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen as determined by the medical monitor.
- •2. Known impaired cardiac function or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, congestive heart failure (New York Heart Association Functional Classification Class 2B-4), and uncontrolled hypertension (defined as systolic blood pressure greater than 150 mm Hg and/or diastolic blood pressure greater than 100 mm Hg while on anti-hypertensive medications).
- •3. Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug.
- •4. History of cerebral vascular disease within 6 months prior to the first administration of study drug.
研究者
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