NCT02567656已完成1 期
A Phase I/Ib, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K δ/γ Inhibitor, in Patients With Relapsed or Refractory T-cell Lymphoma
Rhizen Pharmaceuticals SA8 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 8
- 主要终点
- Safety of RP6530
研究概览
简要总结
The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma.
详细描述
Safety: Treatment-Emergent AE; Treatment-Related AE, SAE and Clinical significant AE; Dose Limiting Toxicities (DLT). PK: Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum concentration observed (Tmax). Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS) and Duration of Response.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed T cell Non-Hodgkin Lymphoma (T-NHL)
- •Refractory to or relapsed after at least 1 prior treatment line.
- •ECOG performance status ≤2
- •Patients must be ≥18 years of age
- •Able to give a written informed consent.
排除标准
- •Any cancer therapy in the last 3 weeks or limited palliative radiation <2 weeks
- •Patients with HBV, HCV or HIV infection
- •Previous therapy with GS-1101 (CAL-101, Idelalisib), IPI-145 (Duvelisib), TGR-1202 or any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus), AKT or BTK Inhibitor (including Ibrutinib) in last 6 months
- •Patients on immunosuppressive therapy including systemic corticosteroids.
- •Patients with known history of liver disorders.
- •Patients with uncontrolled Diabetes Type I or Type II
- •Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
- •Women who are pregnant or lactating.
研究组 & 干预措施
Single arm
Experimental
RP6530 administered orally twice a day.
干预措施: RP6530 (Drug)
结局指标
主要结局
Safety of RP6530
时间窗: 28 days
Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0
次要结局
- Overall Response Rate (ORR) With RP6530(8 months)
- Duration of Response (DOR) With RP6530(24 months)
- Peak Plasma Concentration (Cmax)(Day 1 of Cycle 1)
研究者
研究点 (8)
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