Elsiglutide will be administered to patients with colorectal cancer along with chemotherapy, to assess the efficacy of elsiglutide in preventing the Chemotherapy Induced Diarrhea (CID). Elsiglutide will be given at different doses including placebo group.

• Conditions: Chemotherapy Induced Diarrhea (CID); MedDRA version: 17.1Level: LLTClassification code 10056985Term: Diarrhoea post chemotherapySystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-000998-39-HU
• Lead Sponsor: Helsinn Healthcare SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-14
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1.Written informed consent
2.Male or female patient > 18 years of age;
3.Histologically or cytologically confirmed diagnosis of colorectal cancer;
4.a)Inclusion in the Target Population:
Scheduled to receive at least 3 consecutive cycles of the same regimen of FOLFOX or FOLFIRI (Oxaliplatin/Irinotecan, Folinic acid, 5-FU) without monoclonal antibody;
4.b)Inclusion in the Additional Population:
Scheduled to receive at least 3 consecutive cycles of the same regimen of FOLFOX or FOLFIRI (Oxaliplatin/Irinotecan, Folinic acid, 5-FU) in combination with monoclonal antibody;
5.A performance status of = 2 according to the Eastern Cooperative Oncology Group (ECOG) scale;
6.Non-childbearing female patient or female patient of childbearing potential using reliable contraceptive measures and having negative pregnancy test before treatment administration;
7Able to read, understand, follow the study procedure and complete patient diary.
Inclusion criteria will be checked during the screening visit. Inclusion criteria 4 and 6 will be re-checked as applicable on Day 1 of Cycle 1 and Cycle 2.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

Patients are excluded from this study if they meet any of the following criteria:
1.Any investigational drugs within 30 days before enrollment or foreseen use of investigational agents during the study;
2.Treatment with chemotherapy of any type within 12 months before enrollment;
3.Patient with any type of ostomy (temporary ostomy should be closed at least 6 months prior to enrollment);
4.Patient who underwent total colectomy;
5.Patient who had abdomino-perineal resection or surgery leaving the patient without a functioning rectum;
6.Any radiotherapy to the abdomen or pelvis in the 6 months prior to enrollment;
7.Scheduled to receive radiotherapy to abdomen or pelvis during the study;
8.a)Exclusion from the Target population
Scheduled to receive:
- any concomitant chemotherapeutic agent, other than FOLFOX or FOLFIRI agents (Oxaliplatin/Irinotecan, Folinic acid, 5-FU);
- any type of monoclonal antibodies;
8. b)Exclusion from the Additional population
Scheduled to receive:
- any concomitant chemotherapeutic agent, other than FOLFOX or FOLFIRI agents (Oxaliplatin/Irinotecan, Folinic acid, 5-FU;
9.Any type of condition leading to diarrhea, including but not limited to inflammatory bowel diseases (e.g. ulcerative colitis and Crohn’s disease), diarrhea of presumed or confirmed infectious origin and irritable bowel syndrome, celiac disease, lactose intolerance, pancreas, liver or diverticular disease, alcohol abuse;
10.History of chronic (= 30 consecutive days) use of laxatives;
11.Active and ongoing systemic infection;
12.Lactating woman;
13.History of hypersensitivity or allergies to drugs or compounds potentially related to this investigational drug class;
14.Previous exposure to GLP-2 or other compounds in this investigational drug class;
15.Patient who participated in a previous study with elsiglutide;
16.Patient with abnormalities in selected laboratory parameters, including:
a.Aspartate aminotransferase (AST) = 5 x upper limit of normal
b.Alanine aminotransferase (ALT) = 5 x upper limit of normal
c.Bilirubin > 1.5 x upper limit of normal
d.Creatinine > 2 mg/dL (177 µmol/L)
e.Albumine < 2 g/dL (20 g/L)
f.Neutrophils < 1.5 x109/L
g.Platelet count < 100 x109/L;
17. Any illness or condition that, in the opinion of the investigator, may confound the
results of the study or pose unwarranted risk in administering the investigational
product to the patient;
18. Any medical condition that precludes the administration of chemotherapy;
19. Use of laxatives within 7 days prior to study Day 1;
20. Use of antibiotics within 7 days prior to study Day 1;
21. Any diarrhea in the 48 hours preceding study drug administration on Day 1;
22. Major surgery within the previous 21 days before study Day 1;
23. Use of anti-diarrheal agents and probiotics within the 48 hours prior to study drug
administration on study Day 1.
Exclusion criteria 1 to 18 will be checked during the screening visit. Exclusion criteria 7,
8, 9, 11 and 17 to 23 will be checked on Day 1 of Cycle 1 and Cycle 2.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified