NCT06608927进行中（未招募）3 期
A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 610
- 试验地点
- 157
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxel and gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Have histologically or cytologically confirmed PDAC that is metastatic.
- •Have not been previously treated for PDAC in the metastatic setting.
- •Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization.
- •Prior palliative radiotherapy is allowed if completed at least 2 weeks prior to randomization and AEs have resolved to Grade 1 or less before randomization.
- •Prior and/or placement of a biliary stent/tube is permitted if any treatment-related AEs have improved to Grade ≤ 1 and the patient is not exhibiting any signs/symptoms of biliary obstruction.
- •Eastern Cooperative Oncology Group PS of 0 to
- •At least 1 target lesion measurable by computed tomography (CT)/magnetic resonance imaging (MRI) per RECIST v1.
- •not within a field of prior radiation therapy.
排除标准
- •Previously treated for locally advanced, unresectable PDAC.
- •History of brain metastases or leptomeningeal metastases.
- •Prior treatment with a CD73 antagonist or inhibitor.
- •Underlying medical conditions that, in the investigator or sponsor's opinion, will make the administration of study-specified therapy hazardous
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Arm A (Experimental Arm)
Experimental
Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion
干预措施: Gemcitabine (Drug)
Arm B (Comparator Arm)
Placebo Comparator
Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion
干预措施: Gemcitabine (Drug)
Arm B (Comparator Arm)
Placebo Comparator
Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion
干预措施: Placebo (Drug)
Arm A (Experimental Arm)
Experimental
Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion
干预措施: Quemliclustat (Drug)
Arm A (Experimental Arm)
Experimental
Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion
干预措施: Nab-paclitaxel (Drug)
Arm B (Comparator Arm)
Placebo Comparator
Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 72 months
次要结局
- Disease Control Rate (DCR) as determined by the Investigator according to RECIST v1.1(Up to 72 months)
- Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1(Up to 72 months)
- Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1(Up to 72 months)
- Duration of response (DoR) as determined by the Investigator according to RECIST v1.1(Up to 72 months)
- The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)(Up to 72 months)
研究者
研究点 (157)
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