Study in Colorectal Cancer Patients treated with Chemotherapy to Assess the Efficacy of a new drug (elsiglutide) administered subcutaneously in the prevention of diarrhea induced by chemotherapy

• Conditions: Chemotherapy Induced Diarrhea; MedDRA version: 14.1Level: LLTClassification code 10057013Term: Diarrhea post chemotherapySystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-004981-13-HU
• Lead Sponsor: Helsinn Healthcare SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-17
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

1.Written informed consent;
2.Male or female patient 18 years of age or over;
3.Confirmed diagnosis of colorectal cancer;
4.Chemotherapy naïve patient;
5.Patient scheduled to receive a FOLFOX4 or FOLFIRI chemotherapy regimen
6.A performance status of = 2 according to the Eastern Cooperative Oncology Group (ECOG);
7.Non-fertile patient or fertile patient (male or female) using reliable contraceptive measures;
8.Female patient of childbearing potential need to have a negative pregnancy test at screening.

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 98
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Inability to understand study procedures and/or cooperate with the study Investigator;
2.Any investigational drugs within 30 days before enrollment in the study or foreseen use of investigational agents during the study;
3.Patient with any type of ostomy;
4.Any previous radiotherapy to the abdomen or pelvis;
5.Scheduled to receive radiotherapy to abdomen or pelvis during the study (Day 1 to Day 14);
6.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;
7.Previous use or scheduled to receive monoclonal antibodies (e.g. bevacizumab, cetuximab, etc) during the study (from Day 1 to Day 14);
8.Major surgery within the previous 3 weeks;
9.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;
10.Any diarrhea in the 48 hours preceding study drug administration;
11.Use of anti-diarrheal agents within the 48 hours prior to study drug administration;
12.Use of laxatives within 7 days prior to study drug administration;
13.Use of antibiotics within 7 days prior to study drug administration ;
14.History of chronic (= 30 consecutive days) use of laxatives;
15.Active and ongoing systemic infection;
16.Lactating woman;
17.History of hypersensitivity or allergies to drugs or compounds potentially related to this investigational drug class;
18.Previous exposure to GLP-2 or other compounds in this investigational drug class;
19.Patient with abnormalities in selected laboratory parameters (according to pre-defined criteria);
20.Concomitant bleeding disorders;
21.Other serious concomitant illness, which could interfere with the study;
22.Patient who participated in a previous study with Elsiglutide ZP1846.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this proof of concept study will be to obtain data on the efficacy of Elsiglutide (ZP1846) in preventing CID in patients with colorectal cancer receiving 5-FU based chemotherapy (FOLFOX4 or FOLFIRI regimen) in comparison to placebo.;Secondary Objective: Safety and tolerability of the administered repeated doses of Elsiglutide (ZP1846) will be evaluated and the pharmacokinetics (PK) of Elsiglutide (ZP1846), and its metabolites ZP2242 and ZP2712 will be investigated in a subset of patients in each treatment arm.;Primary end point(s): Number of patients experiencing no diarrhea from Day 1 to Day 14.;Timepoint(s) of evaluation of this end point: Day 1 to Day 14, on a daily basis.