A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
研究概览
简要总结
The primary purpose of this study is to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer.
详细描述
This is a first in humans study that is designed to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Progressive metastatic or locally advanced or metastatic breast cancer.
- •Clinically confirmed as postmenopausal.
- •Eastern Cooperative Oncology Group (ECOG) score of 0 to 1 at screening.
排除标准
- •HER2 positive patients by local laboratory testing.
- •Triple negative breast cancer.
- •Any chemotherapy within the 28 days prior to the first dose of study drug.
- •Any non-chemotherapy anti-cancer drug less than 5 half-lives (30 days for biologics) or less than 14 days for small molecule therapeutics, or if half-life is not known.
- •Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug.
- •Fulvestrant within 30 days prior to first dose of study drug.
- •Any investigational drug therapy within 5 half-lives of the previous investigational study drug or 30 days, whichever is shorter.
- •Radiation therapy for breast cancer within 2 weeks of dosing and planning to have radiation therapy during participation in this study.
- •Known history of human immunodeficiency virus infection (HIV) or hepatitis C or active hepatitis B infection, unless the patient was diagnosed >10 years prior to enrollment and no evidence of active liver disease.
- •Currently taking testosterone, methyltestosterone, oxandrolone (Oxandrin), oxymetholone, danazol, fluoxymesterone (Halotestin), or testosterone-like agents.
- •Untreated or uncontrolled brain metastasis.
- •Diagnosed with or treated for cancer within the previous 2 years, other than breast cancer or non-melanoma carcinoma of the skin.
- •Pregnant and nursing females.
研究组 & 干预措施
RAD140 Part A and Part B
Part A, Dose Escalation: Patients will be assigned sequentially to escalating doses of RAD140.
Part B, Safety Expansion: Once the maximum tolerated dose (MTD) has been identified and/or a recommended dose escalation (RDE) has been determined, additional patients will be enrolled to further evaluate the safety, tolerability and preliminary clinical activity of the recommended dose.
干预措施: RAD140 (Drug)
结局指标
主要结局
Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
时间窗: First 28 days of treatment
Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
Number of adverse events related to study treatment
时间窗: Up to 30 days after end of treatment
Number of adverse events related to study treatment
Number participants with dose interruptions and dose adjustments
时间窗: Up to 30 days after end of treatment
Number participants with dose interruptions and dose adjustments
次要结局
- Time to maximum plasma concentration (Tmax)(Day 1 and 15)
- Maximum plasma concentration (Cmax)(Day 1 and 15)
- Area under the plasma concentration versus time curve (AUC)(Day 1 and Day 15)
- Tumor response(Screening and every 8 weeks for up to 12 months of treatment)