NCT06539182招募中2 期
A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Dizal Pharmaceuticals19 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2024年4月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 155
- 试验地点
- 19
- 主要终点
- Objective Response Rate assessed by investigators
研究概览
简要总结
This study will treat patients with CLL/SLL whose disease comes back or is not responding to prior therapy, or if they can not bear side effects of the prior treatment. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Participants who meet all the following criteria:
- •Male and female ≥ 18 years of age.
- •ECOG performance status 0-
- •Confirmed diagnosis of CLL/SLL with indication for treatment.
- •Adequate bone marrow reserve and organ system functions.
- •Willing to comply with contraceptive restrictions.
排除标准
- •Participants who meet any of the following criteria:
- •CNS involvement or Richter transformation.
- •Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, monoclonal antibodies and antibody-drug conjugates within 28 days.
- •Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
- •Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A inhibitors or inducers.
- •Active infection.
- •Clinically significant cardiac disorders or abnormalities. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
- •Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
- •Another malignancy within 2 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.
- •Women who are breast feeding.
- •History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.
研究组 & 干预措施
Daily dose of DZD8586 at 25 mg
Experimental
干预措施: DZD8586 (Drug)
Daily dose of DZD8586 at 50 mg
Experimental
干预措施: DZD8586 (Drug)
Daily dose of DZD8586 at 75 mg
Experimental
干预措施: DZD8586 (Drug)
结局指标
主要结局
Objective Response Rate assessed by investigators
时间窗: assessed up to 2 years
次要结局
- Incidence of adverse event(30 days after the last dose, assessed up to 2 years)
研究者
研究点 (19)
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