NCT05021900已完成2 期
A Phase II, Multi-center, Randomized, Open-label, Two-arm Study to Assess the Efficacy and Safety of Tenalisib (RP6530), a PI3K δ/γ and SIK3 Inhibitor, in Patients With Locally Advanced or Metastatic Breast Cancer
Rhizen Pharmaceuticals SA3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年10月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Percentage of Patients Without Disease Progression
研究概览
简要总结
Phase II, randomized, open-label study, designed to evaluate the preliminary efficacy and safety of tenalisib at two dose levels in 40 patients with locally advanced or metastatic breast cancer.
详细描述
The study will have two groups, Group 1 with a treatment option of 800mg RP6530 BID and Group 2 with a treatment option of 1200mg RP6530 BID, where the subjects will be randomly assigned to each group in 1:1 and continued on each group of treatment till disease progressed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 ≥18 years of age, at the time of signing informed consent.
- •Female patients who have histologically and/or cytologically confirmed locally advanced or metastatic breast cancer that has progressed following at least one line of therapy.
- •Patients with at least one measurable lesion per RECIST version 1.1 at baseline that can be accurately assessed by CT scan or MRI and is suitable for repeated assessment at follow up-visits.
- •ECOG performance status 0 to
- •Life expectancy of at least 3 months.
- •Adequate bone marrow, liver, and renal functions
- •Female patients of childbearing potential should be willing to use a medically acceptable method of contraception
排除标准
- •Patients with HER-2 positive breast cancer.
- •Patients receiving anticancer therapy within 4 weeks or 5 half-lives of the drug prior to C1D1, whichever is shorter.
- •Patient who has not recovered from acute toxicities (defined as NCI-CTCAE grade > 1) of previous therapy except treatment-related alopecia.
- •Patients who have had disease progression within 8 weeks of platinum chemotherapy.
- •Prior exposure to investigational or marketed PI3K inhibitors given for the treatment of breast cancer.
- •Major surgery within 4 weeks of starting study treatment OR any patient who has not recovered from the effects of major surgery.
- •Patient with symptomatic uncontrolled brain metastasis.
- •HIV-positive patients who are on antiretroviral therapy OR active hepatitis C OR active hepatitis B virus infections.
- •Ongoing immunosuppressive therapy including systemic corticosteroids except as allowed per concomitant medication.
- •Known history of severe liver injury as judged by the investigator.
- •History of severe cutaneous reactions in the past.
- •Active gastrointestinal tract disease with malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease such as Crohn's disease or ulcerative colitis.
- •Pregnancy or lactation.
- •Patient with other active malignancies at the time of screening.
研究组 & 干预措施
Tenalisib 800 mg BID
Experimental
Single agent at a dose of 800 mg BID
干预措施: Tenalisib 800mg (Drug)
Tenalisib 1200 mg BID
Experimental
Single agent at a dose of 1200 mg BID
干预措施: Tenalisib 1200mg (Drug)
结局指标
主要结局
Percentage of Patients Without Disease Progression
时间窗: Approximately 6 months
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Clinical Benefit Rate (CBR)(Approximately 18 months)
- Overall Response Rate (ORR)(Approximately 18 months)
- Progression Free Survival (PFS).(Approximately 18 months)
- Treatment Emergent Adverse Events (TEAEs)(Approximately 18 months)
研究者
研究点 (3)
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