Creon (Pancrelipase) Therapy for Subjects With Exocrine Pancreatic Insufficiency (EPI) Due to Pancreatic Cancer: A Double-blind, Randomized, Parallel Design With 2 Dose Cohorts of Pancrelipase in Resected Pancreatic Cancer Subjects and an Open-label Single Dose Cohort in Non-resected Pancreatic Cancer Subjects
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 33
- 主要终点
- Change in Stool Fat From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer
研究概览
简要总结
This is a study in participants with Exocrine Pancreatic Insufficiency (EPI) due to pancreatic cancer. This study will include resected participants who are post pancreatic cancer surgery, and an additional cohort in non-resected participants.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has diagnosed cancer of pancreas with biopsy and/or radiography, with a life expectancy of at least 5 months at screening
- •Participant's pancreatic cancer must involve the head and/or neck of the pancreas
- •Confirmed exocrine pancreatic insufficiency (EPI) as evidenced by fecal elastase-1 (FE-1) ≤ 150 µg/g stool at screening
- •A positive Sudan stain for participants without history of fat malabsorption (fat malabsorption is defined as clinical steatorrhea, or measured stool fat > 7 g/day, or positive stool results by Sudan stain) within 1 week of screening -- Positive stool results are defined as increased level of neutral OR total fats
排除标准
- •Participant has neuroendocrine pancreatic cancer
- •Participant has fibrosing colonopathy
- •Participant has any other malignancy within 1 year of screening
- •Participant has uncontrolled gout, including those with a recent flare within 60 days of screening
- •Participant has other significant organ or bone marrow abnormality within 60 days of screening
研究组 & 干预措施
Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase
Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
干预措施: Pancrelipase (Drug)
Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase
Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
干预措施: Placebo (Drug)
Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase
Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
干预措施: Pancrelipase (Drug)
Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase
Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.
干预措施: Placebo (Drug)
Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase
Non-resected participants (those who did not have surgery to remove pancreatic cancer) will receive high dose pancrelipase throughout the study in an open-label cohort. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks.
干预措施: Pancrelipase (Drug)
结局指标
主要结局
Change in Stool Fat From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer
时间窗: Baseline (Day 1), Week 1 (Day 8)
Stool samples were collected during the 48 hours prior to the Day 1 and Week 1 visits and analyzed for fat content.
次要结局
- Change in Average Daily Stool Frequency From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer(Baseline (Day 1), Week 1 (Day 8))
- Change in Stool Consistency From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer(Baseline (Day 1), Week 1 (Day 8))
- Change in the Total EPI Symptoms Score From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer(Baseline (Day 1), Week 1 (Day 8))