A Phase I, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K Delta/Gamma Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose (MTD) and pharmacokinetics (PK) of RP6530
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with hematologic malignancies.
详细描述
The Maximum tolerated dose (MTD) will be determined based on the safety, pharmacokinetic (PK) and efficacy data. Safety analyses include AE's, AE's related to the drug, SAE's, laboratory values, vitals/ ECG and dose limiting toxicity (DLT). PK include measurement of peak plasma concentration (Cmax), area under the plasma concentration versus the time curve (AUC), time of maximum concentration observed (Tmax). Efficacy analyses include overall response rate (ORR) and duration of response (DOR).
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
- •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 4 weeks or limited palliative radiation <2 weeks
- •Patients with HBV, HCV or HIV infection
- •Autologous hematologic stem cell transplant within 3 months of study entry. Allogeneic hematologic stem cell transplant within 12 months.
- •Previous therapy with GS-1101 (CAL-101, idelalisib), IPI-145, TGR-1202 or any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus), AKT or BTK Inhibitor (including Ibrutinib).
- •Patients on immunosuppressive therapy including systemic corticosteroids.
- •Patients who are receiving chronic systemic anticoagulation therapy (warfarin sodium or heparin, etc.).
- •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
RP6530 administered orally
干预措施: RP6530 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) and pharmacokinetics (PK) of RP6530
时间窗: 28 days
* To access maximum tolerated dose by clinical laboratory assessments, adverse events and dose limiting toxicities. * PK parameter AUC, Cmax, tmax, t1/2 will be determined.
次要结局
- Clinical response following administration of RP6530(8 weeks)