A Randomized Phase 2 Placebo-Controlled Study of LY2495655 in Patients With Advanced or Metastatic Pancreatic Cancer Receiving Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial in participants with locally advanced/inoperable or metastatic pancreatic cancer, and will investigate 2 different doses of LY2495655 in combination with standard of care chemotherapy.
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
- Triple (Participant, Care Provider, 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
300 mg LY2495655 + chemotherapy
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)
干预措施: LY2495655 (Drug)
300 mg LY2495655 + chemotherapy
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)
干预措施: Standard of Care Chemotherapy (Drug)
100 mg LY2495655 + chemotherapy
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)
干预措施: LY2495655 (Drug)
100 mg LY2495655 + chemotherapy
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)
干预措施: Standard of Care Chemotherapy (Drug)
Placebo + chemotherapy
Placebo in combination with standard of care chemotherapy (investigator's choice)
干预措施: Placebo (Drug)
Placebo + chemotherapy
Placebo in combination with standard of care chemotherapy (investigator's choice)
干预措施: Standard of Care Chemotherapy (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Baseline to Death from Any Cause (Up to 23 months)
Overall survival (OS) duration was measured from the date of randomization to the date of death from any cause.
次要结局
- Duration of Response(First CR or PR to Disease Progression (Up to 11 months))
- Change in Physical Performance Measures Using Hand Grip Strength(Baseline, Cycles 2, 4, 6, 8 and 10; Day 1)
- Change in Lean Body Mass(Baseline, Cycles 3, 5, 7, 9 and 11; Day 1)
- Progression Free Survival (PFS)(Baseline to Disease Progression or Death from Any Cause (Up to 16 months))
- Percentage of Participants With Tumor Response Rate (RR)(Baseline to Disease Progression (Up to 11 months))
- Change in Physical Performance Measures Using the 6 Minute Walk Test(Baseline, Cycles 2, 4, 6, 8 and 10; Day 1)
- Change in Physical Performance Measures Using the Time Up and Go (TUG) Test(Baseline, Cycles 2, 4, 6, 8 and 10; Day 1)
- Change in Physical Performance Measures Using Stair Climbing Time (StC)(Baseline, Cycles 3, 5, 7, 9 and 11; Day 1)
- Change in Patient Reported Outcomes (PRO)(Baseline, Cycles 2, 4, 6, 8 and 10; Day 1)
- Change in Pain Scale Physical Functioning(Baseline, Cycles 2, 4, 6, 8 and 10; Day 1)
- Number of Participants With Anti-LY2495655 Antibodies(Cycle 1, Day 1 and Day 29 (Pre-Dose); Cycle 6 Day 1)