2023-503903-27-00进行中（未招募）2 期
CT7001_002 (SUMIT-BC) - An open-label Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant with or without Samuraciclib in Participants with Metastatic or Locally Advanced Hormone Receptor Positive and Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- Clinical benefit response (CBR) (complete response [CR], partial response [PR], or stable disease [SD] (≥ 24 weeks after randomization)).
研究概览
简要总结
To evaluate the efficacy of two doses of samuraciclib in combination with fulvestrant.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed diagnosis of BC. Evidence of metastatic or locally advanced disease, not amenable to resection or radiation therapy with curative intent and having the following specifics: estrogen receptor positive with or without progesterone receptor positive tumor; HER2-negative.
- •Documented objective disease progression while on or within 6 months after the end of the most recent therapy.
- •Received prior AI in combination with a CDK4/6i in the following settings: locally advanced or metastatic, or adjuvant.
- •Known TP53 mutation status.
- •Participants must have measurable disease or bone only disease (which can be measurable or non-measurable) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •Pre/peri-menopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of study intervention.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no deterioration over the past 2 weeks.
- •Expected life expectancy of >12 weeks in the judgement of the treating investigator.
排除标准
- •Inflammatory BC.
- •Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- •Prior treatment with: a selective estrogen receptor degrader (SERD) or similar agents in the advanced/metastatic setting; more than 1 line of endocrine treatment for locally advanced or metastatic disease treatment.
- •Inadequate hepatic, renal, and bone marrow function.
- •Clinically significant cardiovascular disease.
- •Any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
- •Pregnant or breastfeeding women.
结局指标
主要结局
Clinical benefit response (CBR) (complete response [CR], partial response [PR], or stable disease [SD] (≥ 24 weeks after randomization)).
Clinical benefit response (CBR) (complete response [CR], partial response [PR], or stable disease [SD] (≥ 24 weeks after randomization)).
次要结局
- Adverse events (AEs) and laboratory abnormalities as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- Progression free survival (PFS); Objective response rate (ORR); Duration of response (DOR).
- Samuraciclib: Cmax and Ctrough; Fulvestrant: Ctrough.
研究者
Sheila O'Mahony
Scientific
Carrick Therapeutics Limited
研究点 (5)
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