A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Subjects With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 492
- 试验地点
- 216
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).
详细描述
Participants will be randomized in a 2:1 ratio to PAG or AG treatment.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PAG: PEGPH20 + nab-Paclitaxel + Gemcitabine
Participants will receive 3.0 micrograms/kilogram (μg/kg) PEGPH20 as an intravenous (IV) infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks [Week 4 of every cycle will be a rest week with no treatment]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 milligrams/square meter (mg/m^2) nab-paclitaxel as an IV infusion and 1000 mg/m^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment will continue until disease progression, unacceptable toxicity, death, or withdrawal of consent.
干预措施: nab-Paclitaxel (Drug)
PAG: PEGPH20 + nab-Paclitaxel + Gemcitabine
Participants will receive 3.0 micrograms/kilogram (μg/kg) PEGPH20 as an intravenous (IV) infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks [Week 4 of every cycle will be a rest week with no treatment]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 milligrams/square meter (mg/m^2) nab-paclitaxel as an IV infusion and 1000 mg/m^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment will continue until disease progression, unacceptable toxicity, death, or withdrawal of consent.
干预措施: Gemcitabine (Drug)
AG: Placebo + nab-Paclitaxel + Gemcitabine
Participants will receive placebo matching to PEGPH20 as an IV infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks [Week 4 of every cycle will be a rest week with no treatment]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 mg/m^2 nab-paclitaxel as an IV infusion and 1000 mg/m^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment will continue until disease progression, unacceptable toxicity, death, or withdrawal of consent.
干预措施: Placebo (Drug)
AG: Placebo + nab-Paclitaxel + Gemcitabine
Participants will receive placebo matching to PEGPH20 as an IV infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks [Week 4 of every cycle will be a rest week with no treatment]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 mg/m^2 nab-paclitaxel as an IV infusion and 1000 mg/m^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment will continue until disease progression, unacceptable toxicity, death, or withdrawal of consent.
干预措施: nab-Paclitaxel (Drug)
AG: Placebo + nab-Paclitaxel + Gemcitabine
Participants will receive placebo matching to PEGPH20 as an IV infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks [Week 4 of every cycle will be a rest week with no treatment]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 mg/m^2 nab-paclitaxel as an IV infusion and 1000 mg/m^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment will continue until disease progression, unacceptable toxicity, death, or withdrawal of consent.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall Survival
时间窗: From randomization until death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Overall survival was defined as the time from randomization until death from any cause. Overall survival was analyzed using Kaplan-Meier methods.
次要结局
- Objective Response Rate (ORR): Percentage of Participants With Objective Response(From the date of randomization until CR or PR (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG))
- Number of Participants With Worst Post-Baseline Hematology and Chemistry (Clinical Laboratory Parameters) Severity Grade During the Study(From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG))
- Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)(From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG))
- Progression-Free Survival (PFS)(From the date of randomization until disease progression or death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG))
- Duration of Response (DOR)(From date of first objective response (CR or PR) until date of first disease progression (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG))
- Number of Participants With Treatment-Emergent Adverse Events (AEs)(From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG))
- Number of Participants With Clinically Significant Abnormalities in Vital Signs(From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG))