NCT01543451已完成2 期
Phase II, Double-blind, Randomized, Two-stage, Placebo-controlled Proof of Concept Study in Colorectal Cancer Patients Receiving 5-FU Based Chemotherapy to Assess the Efficacy of Elsiglutide (ZP1846)Administered s.c. in the Prevention of Chemotherapy Induced Diarrhea(CID)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 20
- 主要终点
- Number of Patients experiencing Diarrhea
研究概览
简要总结
The main objective of this study will be to obtain data on the efficacy of elsiglutide in preventing Chemotherapy Induced Diarrhea (CID) in patients with colorectal cancer receiving 5-FU based chemotherapy (FOLFOX4 or FOLFIRI regimen) in comparison to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Written informed consent;
- •Male or female patient ≥ 18 years of age;
- •Confirmed diagnosis of colorectal cancer;
- •Chemotherapy naïve patient;
- •Patient scheduled to receive a FOLFOX4 or FOLFIRI chemotherapy regimen according to the following scheme and dosage (1st cycle):
- •AGENT DOSE ROUTE/DURATION DAYS Oxaliplatin or Irinotecan 85/180 mg m2 i.v. infusion/2h 1 FolinicAcid (leucovorin) 200 mg m2 i.v. infusion/2h 1+2 5-Fluorouracil (5FU) 400 mg m2 i.v. bolus 1+2 5-Fluorouracil (5FU) 600 mg m2 i.v. infusion/22h 1+2
- •A performance status of ≤ 2 according to the Eastern Cooperative Oncology Group(ECOG);
- •Non-fertile patient or fertile patient (male or female) using reliable contraceptive measures
- •Female patient of childbearing potential; need to have a negative pregnancy test at screening.
- •Inclusion criteria 1-8 will be verified at screening.
- •Inclusion criteria 8 will be re-confirmed on Day 1.
排除标准
- •Inability to understand study procedures and/or cooperate with the study Investigator;
- •Any investigational drugs within 30 days before enrollment in the study or foreseen use of investigational agents during the study;
- •Patient with any type of ostomy;
- •Any previous radiotherapy to the abdomen or pelvis;
- •Scheduled to receive radiotherapy to abdomen or pelvis during the study (Day 1 to Day 14);
- •Scheduled to receive any concomitant chemotherapeutic agent other than FOLFOX4 or FOLFIRI agents (Oxaliplatin, Irinotecan, Folinic acid, 5-FU) from Day 1 to Day 14;
- •Previous use or scheduled to receive monoclonal antibodies (e.g. bevacizumab, cetuximab, etc) during the study (From Day 1 to Day 14);
- •Major surgery within the previous 3 weeks;
- •Any type of condition leading to chronic diarrhea, including but not limited to inflammatory bowel diseases (e.g. ulcerative colitis and Crohn's disease), chronic diarrhea of presumed or confirmed infectious origin and irritable bowel syndrome;
- •Any diarrhea in the 48 hours preceding study drug administration;
- •Use of anti-diarrheal agents within the 48 hours prior to study drug administration;
- •Use of laxatives within 7 days prior to study drug administration;
- •Use of antibiotics within 7 days prior to study drug administration;
- •History of chronic (≥ 30 consecutive days) use of laxatives;
- •Active and ongoing systemic infection;
- •Lactating woman;
- •History of hypersensitivity or allergies to drugs or compounds potentially related to this investigational drug class;
- •Previous exposure to GLP-2 or other compounds in this investigational drug class;
- •Abnormal laboratory values, including
- •Aspartate aminotransferase (AST) ≥ 5 x upper limit of normal
- •Alanine aminotransferase (ALT) ≥ 5 x upper limit of normal
- •Bilirubin > 2 mg/dL (34 μmol/L)
- •Creatinine > 2 mg/dL (177 μmol/L)
- •Albumine < 2 g/dL (20 g/L)
- •Neutrophils< 1.5 x109/L
- •Platelet count < 100 x109/L;
- •Concomitant bleeding disorders;
- •Other serious concomitant illness, which could interfere with the study;
- •Patient who participated in a previous study with elsiglutide (ZP1846).
- •Exclusion criteria 1-9 and 12-22 will be verified at screening. Exclusion criteria 10 and 11 will be checked on Day 1 only. Exclusion criteria 12, 13 and 15 will be re-checked on Day 1.
研究组 & 干预措施
Elsiglutide
Experimental
干预措施: Elsiglutide (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Patients experiencing Diarrhea
时间窗: Day 1 to Day 14
Severity of Diarrhea will be classified according to the NCI-CTCAE.
次要结局
- Safety and tolerability of the administered repeated doses of elsiglutide (ZP1846) will be evaluated(Day 1 to Day 32)
- PK of elsiglutide will be evaluated(Day 1 to Day 5)
研究者
研究点 (20)
Loading locations...
相似试验
已完成
2 期
Safety and Efficacy of Liraglutide in Parkinson's DiseaseParkinson DiseaseNCT02953665Cedars-Sinai Medical Center63
已完成
3 期
Safety and Efficacy Study of Albiglutide in Type 2 DiabetesDiabetes Mellitus, Type 2NCT00849017GlaxoSmithKline309
Unknown
2 期
Monosialoganglioside Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer PatientsNeurotoxicityNCT02500810Peking University Cancer Hospital & Institute106
已完成
3 期
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBSShort Bowel SyndromeNCT03905707Zealand Pharma150
已完成
3 期
Effect of Ertugliflozin on Cardiac Function in DiabetesType2 DiabetesHeart FailureNCT03717194Soo Lim102