A Phase I/IIa Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Rivoceranib in Combination With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Phase I: Incidence of Dose-Limiting Toxicities (DLT) During Cycle 1
研究概览
简要总结
This is an open-label, single-center, single-arm, dose escalation and dose expansion Phase I/IIa study designed to determine the recommended Phase 2 dose (RP2D) and the safety and tolerability profile along with preliminary signs of efficacy of rivoceranib in combination with paclitaxel as a second-line therapy in advanced, recurrent and/or metastatic gastric or gastroesophageal junction cancer. This study will also characterize the pharmacokinetic (PK) parameters of rivoceranib and paclitaxel when given in combination.
详细描述
Primary Phase I Objectives
- To determine the RP2D dose of rivoceranib in combination with paclitaxel.
Primary Phase II Objectives
- To determine clinical activity of the combination of rivoceranib and paclitaxel.
Secondary Phase I Objectives
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rivoceranib with Paclitaxel
Participants will receive oral daily doses of rivoceranib per 28-day cycle (as its mesylate salt) with a fixed dose of paclitaxel given intravenously on Day 1, Day 8, and Day 15 of the 28-day cycle.
干预措施: Rivoceranib (Drug)
Rivoceranib with Paclitaxel
Participants will receive oral daily doses of rivoceranib per 28-day cycle (as its mesylate salt) with a fixed dose of paclitaxel given intravenously on Day 1, Day 8, and Day 15 of the 28-day cycle.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Phase I: Incidence of Dose-Limiting Toxicities (DLT) During Cycle 1
时间窗: Cycle 1 (first 28 days)
The number and proportion of participants experiencing DLTs will be reported by dose level, based on DLT observations during Cycle 1. Each Cycle is 28 days.
Phase I: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs)
时间窗: Up to 24 months
An AE is any untoward medical occurrence in a participant or participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent 1 of the other outcomes listed above.
Phase II: Objective Response Rate (ORR)
时间窗: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
ORR is the percentage of participants who achieve objective tumor response (complete response \[CR\] or partial response \[PR\]) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for response.
次要结局
- Phase I: Maximum Observed Concentration (Cmax)(Day 1 & 15 of Cycle 1 (each cycle is 28 days))
- Phase I: Time to Maximum Observed Concentration (tmax)(Day 1 & 15 of Cycle 1 (each cycle is 28 days))
- Phase I: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-t)(Day 1 & 15 of Cycle 1 (each cycle is 28 days))
- Phase I: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞)(Day 1 & 15 of Cycle 1 (each cycle is 28 days))
- Phase I: Terminal Half-life (t1/2)(Day 1 & 15 of Cycle 1 (each cycle is 28 days))
- Phase I: Apparent Oral Plasma Clearance (CL/F)(Day 1 & 15 of Cycle 1 (each cycle is 28 days))
- Phase I: Apparent Volume of Distribution (Vz/F)(Day 1 & 15 of Cycle 1 (each cycle is 28 days))
- Phase I: Terminal Rate Constant (λz)(Day 1 & 15 of Cycle 1 (each cycle is 28 days))
- Phase I: ORR(Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months)
- Phase I: Progression-free Survival (PFS)(Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months)
- Phase I: Overall survival (OS)(Ongoing assessment from enrollment until end of study, up to approximately 24 months)
- Phase I: Disease Control Rate (DCR)(Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months)
- Phase I: Duration of Response(Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months)
- Phase II: PFS(Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months)
- Phase II: OS(Ongoing assessment from enrollment until end of study, up to approximately 24 months)
- Phase II: DCR(Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months)
- Phase II: Duration of Response(Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months)
- Phase II: Number of Participants With AEs and SAEs(Ongoing assessment from enrollment until end of study, approximately 24 months)
- Phase II: Concentration at the End of the Dosage Interval (Ctrough)(Ongoing assessment from enrollment until end of study, approximately 24 months)