NCT04197999终止1 期
A Phase 1b, Single and Multiple Dose, Open-Label Trial of Intravenous GMI-1359 in HR+ Metastatic Breast Cancer Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Occurrences of dose-limiting toxicities (DLT) including protocol-defined adverse events (AEs)/serious adverse events (SAEs), and/or laboratory abnormalities will be assessed in order to determine recommended phase II dose (Safety and Tolerability)
研究概览
简要总结
This trial is being conducted to investigate the safety, tolerability, pharmacokinetics (the effect the body has on the drug), and pharmacodynamics (the effect the drug has on the body) of GMI-1359 when given with standard-of-care treatment to subjects with HR+ metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed HR+ metastatic breast cancer, currently stable or minimally progressive on current endocrine-based therapy.
- •Continuing on current endocrine-based therapy with an aromatase inhibitor, selective estrogen receptor degrader, or selective estrogen receptor modulator; and must be medically eligible to remain on this therapy during the treatment period.
排除标准
- •Uncontrolled acute life-threatening bacterial, viral, or fungal infection.
- •Subjects who are pregnant or breastfeeding
- •Concurrent treatment with any cytotoxic chemotherapy agent or other targeted therapies including HER2 targeting therapies
- •Currently receiving, or less than 28 days since ending treatment on another investigational drug.
- •Clinically significant cardiovascular disease.
- •Abnormal liver function.
- •Any medical, psychiatric, or other condition which, in the opinion of the investigator, is likely to interfere with trial completion, assessments, or interpretation of trial results, or otherwise would make the subject an inappropriate subject for this trial.
研究组 & 干预措施
Single Ascending Dose followed by Multiple Doses
Experimental
Up to 3 single ascending doses of GMI-1359 followed by the highest tolerated dose given for 3 consecutive days.
干预措施: GMI-1359 (Drug)
结局指标
主要结局
Occurrences of dose-limiting toxicities (DLT) including protocol-defined adverse events (AEs)/serious adverse events (SAEs), and/or laboratory abnormalities will be assessed in order to determine recommended phase II dose (Safety and Tolerability)
时间窗: Up to 4 months
次要结局
- Maximum plasma concentration [Cmax] of GMI-1359(Up to 16 weeks)
- Total plasma clearance [CL] of GMI-1359(Up to 16 weeks)
- Individual estimate of the terminal elimination rate constant [Λz] of GMI-1359(Up to 16 weeks)
- Area under the plasma concentration-time curve [AUC0-t and AUC0-∞] of GMI-1359(Up to 16 weeks)
- Time to reach maximum plasma concentration [tmax] of GMI-1359(Up to 16 weeks)
- Half-life [t1/2] of GMI-1359(Up to 16 weeks)
- Apparent volume of distribution estimated at the terminal phase [Vz] of GMI-1359(Up to 16 weeks)
- Pre-and post-dose CD34+ cell quantification to determine mobilization into peripheral blood [standard flow cytometry](Up to 16 weeks)
- Pre- and post-dose circulating tumor cells (CTC) enumeration to determine tumor cell mobilization [digital pathology assay](Up to 16 weeks)
研究者
研究点 (1)
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