A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicities (DLT)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of elacestrant (RAD1901) in patients with advanced ER+, HER2-negative breast cancer.
详细描述
The primary objective is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of elacestrant in patients with advanced ER+HER2-negative breast cancer.
The secondary objectives of this study are:
- To assess the safety and tolerability of elacestrant
- To evaluate the pharmacokinetics (PK) of elacestrant
- To evaluate the preliminary anti-tumor effect of elacestrant
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
- •Patients must be post-menopausal women, as defined in the protocol
- •18 years or older
- •Patients with histological or cytological proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced, inoperable and/or metastatic disease
- •Part A, B, C: Patients must have received no more than 2 prior chemotherapeutic regimens and at least 6 months of prior endocrine therapy
- •Part D: Patients may have received up to 1 previous line of chemotherapy and must have previously received 2 or more lines of endocrine therapy for advanced/metastatic breast cancer as a single agent or in combination. Patients must have received fulvestrant as one of the previous lines of endocrine therapy and have had documented progression while on, or within 1 month after the end of, fulvestrant therapy for advanced/metastatic breast cancer. Patients must have received prior treatment with a CDK4/6 inhibitor
- •Note: This list is not complete. Further inclusion criteria is provided in the protocol synopsis.
排除标准
- •Prior anticancer or investigational drug treatment within the following windows:
- •Tamoxifen therapy less than 14 days before first dose of study treatment
- •Part A, B and C: Fulvestrant therapy less than 90 days before first dose of study treatment. Part D: Fulvestrant therapy less than 42 days before first dose of study treatment
- •Any other anti-cancer endocrine therapy less than 14 days before first dose of study treatment
- •Any chemotherapy less than 28 days before first dose of study
- •Any investigational drug therapy less than 28 days or 3 half-lives (whichever is longer) prior to first dose of study treatment
- •Patients with untreated or symptomatic central nervous system (CNS) metastases
- •Patients with endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding or cysts
- •Note: This list is not complete. Further exclusion criteria is provided in the protocol synopsis.
研究组 & 干预措施
Elacestrant
Part A, Dose Escalation: Patients will be assigned sequentially to escalating doses of elacestrant.
Part B, Safety Expansion: Once the MTD has been identified and/or a RP2D has been selected, additional patients will be enrolled to further evaluate the safety, tolerability and preliminary efficacy of the RP2D.
Part C, Tablet Introduction: A cohort of patients will be enrolled to evaluate the safety, tolerability, and PK of a tablet dosage form at 400 mg QD.
Part D, Dose Expansion: A cohort of patients will be enrolled to evaluate the safety, tolerability, PK and preliminary anti-tumor effect of elacestrant in tablet dosage form at 400 mg QD PO in a group of patients with a more homogeneous prior treatment history
干预措施: Elacestrant (Drug)
结局指标
主要结局
Dose Limiting Toxicities (DLT)
时间窗: The first 28 days of treatment.
To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of Elacestrant (RAD1901), the incidence of Dose Limiting toxicities (DLTs) will be assessed.
次要结局
- Safety and Tolerability of Elacestrant (RAD1901)(Up to 30 days after the end of treatment.)
- Pharmacokinetics of Elacestrant (RAD1901)(Every 28 days)
- Anti-Tumor Effect of Elacestrant (RAD1901)(Every 8 weeks)