A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients With Relapsed or Refractory Lymphomas
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 11
- 主要终点
- Maximum Tolerated Dose (MTD) Determination
研究概览
简要总结
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or Refractory Lymphomas
详细描述
Safety: Treatment-Emergent Adverse Events (AE); Treatment related AE, Serious Adverse Events (SAE) and Clinical significant AE; Dose Limiting Toxicities (DLT).
Pharmacokinetics (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 (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.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- •Patients must be ≥18 years of age
- •Able to give a written informed consent.
排除标准
- •Patients receiving cancer therapy within 3 weeks prior to Cycle1 Day1 (C1D1).
- •Patients with active Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human immune deficiency virus (HIV) infection
- •Patients who received Allo-Stem cell Transplantation(Allo-SCT) within 12 months.
- •Patients with graft versus-host disease (GVHD)
- •Subjects who have received drugs that directly or indirectly inhibit calcineurin or Nuclear Factor of activated T cells (NFAT) activity .
- •Patient with symptomatic, or history of documented congestive heart failure (NY Heart Association functional classification III-IV);
- •Patient with Frederica's (QTcF) formulas (QTcF) ≥450 msec;
- •Patient with angina not well-controlled by medication;
- •Women who are pregnant or lactating.
研究组 & 干预措施
Single arm
RP4010 to be administered
干预措施: RP4010 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) Determination
时间窗: 28 days
To determine the maximum tolerated dose of RP4010 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma
次要结局
- Maximum Plasma Concentration (Cmax).(24 hrs)
- Area under the curve (AUC)(24 hrs)
- Anti-tumor activity-Overall response rate (ORR)(2 months)