NCT04438044进行中（未招募）2 期
A Phase II, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of ICP-022 in Patients With Recurrent/Refractory Central Nervous System Lymphoma and Recurrent/Refractory Secondary Central Nervous System Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 61
- 试验地点
- 5
- 主要终点
- The efficacy measured by overall response rate (ORR)
研究概览
简要总结
The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.
详细描述
Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with Recurrent/Refractory Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL) will be evaluated in approximately 82 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects .
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 18, and ≤75 years of age
- •Histologically documented PCNSL, or histologically documented systemic diffuse large B-cell lymphoma (DLBCL) for SCNSL.
- •Subjects with refractory or relapsed disease, one prior CNS directed therapy, and ≤ 4 systemic treatments.
- •ECOG performance status of 0-2
- •Able to provide signed written informed consent
排除标准
- •Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded
- •T-cell lymphoma.
- •Patient requires more than 8 mg of dexamethasone daily or the equivalent.
- •Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (except for alopecia)
- •Known active infection with HBV, HCV or HIV.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
ICP-022
Experimental
150mg,QD
干预措施: ICP-022 (Drug)
结局指标
主要结局
The efficacy measured by overall response rate (ORR)
时间窗: Cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days
次要结局
- The efficacy measured by duration of response (DOR)(cycle 1-6 once every 2 cycles; monre than 6 cycles once every 3 cycles. Each cycle is 28 days)
- The efficacy measured by progression free survival (PFS)(cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days)
- The occurrence of adverse events and serious adverse events(every cycle, first cycle every week. Each cycle is 28 days)
研究者
研究点 (5)
Loading locations...
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