A Phase II Trial to Evaluate the Efficacy of AZD6094 (HMPL-504) in Patients With Papillary Renal Cell Carcinoma (PRCC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Objective Response Rate (RECIST Version 1.1)
研究概览
简要总结
This is an open-label, single-arm, multicentre, global, phase II study designed to evaluate the efficacy and safety of AZD6094 in patients with papillary renal cell carcinoma (PRCC) who are treatment naïve or previously treated.
An independent central pathology review of tumour samples will be used to confirm the diagnosis of PRCC of all patients enrolling. However, locally available pathology results confirming PRCC will be allowed for timely study entry.
详细描述
The study will comprise two stages. In Stage 1 approximately 20 patients will be enrolled. This group is considered sufficient to provide preliminary assessment of the anti-tumour activity of AZD6094 in the form of non-binding futility analysis.
If ≤ 2 tumour responses are observed in the first 20 evaluable patients termination of the study will be considered taking into account the relevant molecular profile of the patients and additional information from related studies in the drug development programme.
All patients entering the study will take AZD6094 600 mg by mouth (PO) once daily (QD). Treatment will be given continuously.
Following the baseline assessment, efficacy will be assessed by objective tumour assessments every 6 weeks (±7 days), for the first 12 months and every 12 weeks thereafter until objective disease progression as defined by RECIST v1.1 There will be a data cut-off after all patients have completed at least 12 weeks of treatment with AZD6094 or withdrawn. The database will be locked and data analysis will be performed on this dataset.
Any patients still receiving study drug at the time of data cut-off will be able to continue to receive AZD6094 while deriving clinical benefit. Such patients will continue to be monitored for the occurrence of serious adverse events up to 28 days after the last dose of AZD6094.
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 99 Years（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
AZD6094 600 mg daily continuously
All patients entering the study will take AZD6094 600 mg by mouth (PO) once daily (QD). Treatment will be given continuously.
干预措施: AZD6094 (Drug)
结局指标
主要结局
Objective Response Rate (RECIST Version 1.1)
时间窗: Up to 12 months
The primary outcome measure was Objective Response Rate (ORR), defined as the proportion of patients with either a complete response or a partial response by investigator assessment according to Response Evaluation Criteria for Solid Tumours (RECIST) v1.1.
Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Efficacy Analysis Set
时间窗: 12 Months
The primary outcome measure was ORR, defined as the proportion of patients with either a complete response or a partial response by investigator assessment according to RECIST v1.1.
Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Safety Analysis Set
时间窗: 12 Months
The primary outcome measure was ORR, defined as the proportion of patients with either a confirmed complete response/partial response by investigator assessment according to RECIST v1.1.
次要结局
- Overall Survival Stratified by c-MET Status in the Efficacy Analysis Set(Up to 12 months)
- Area Under Plasma Concentration Time Curve for AZD6094 After Single Dose (Time Zero to Last Measurement)(24 Hours)
- Peak Plasma Concentration of AZD6094 Following Single Dose(24 Hours)
- Progression Free Survival Stratified by c-MET Status in the Safety Analysis Set(Up to 12 months)
- Overall Survival Stratified by c-MET Status in the Safety Analysis Set(Up to 12 months)
- Time to Peak Plasma Concentration of AZD6094 After Single Dose(24 Hours)
- Elimination Half-Life of AZD6094 After Single Dose(24 Hours)
- Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Efficacy Analysis Set(12 Weeks (at 12 weeks timepoint))
- Duration of Response(Up to 12 months)
- Area Under Plasma Concentration Time Curve for AZD6094 After Single Dose(24 Hours)
- Apparent Total Clearance of AZD6094 From Plasma After Single Dose(24 Hours)
- Mean Residence Time of AZD6094 After Single Dose(24 Hours)
- Progression Free Survival Stratified by c-MET Status in the Efficacy Analysis Set(Up to 12 months)
- Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Safety Analysis Set.(12 Weeks (at 12 week timepoint))
- Apparent Volume of Distribution of AZD6094 Following Single Dose(24 Hours)