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Dose Finding Study in Colorectal Cancer Patients Receiving 5-FU-based Chemotherapy to Assess the Efficacy of Elsiglutide in the Prevention of Chemotherapy Induced Diarrhea (CID)

Primary Purpose

Drug and/or Toxin-induced Diarrhea

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Elsiglutide

Placebo

About this trial

This is an interventional prevention trial for Drug and/or Toxin-induced Diarrhea focused on measuring Chemotherapy Induced Diarrhea (CID)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent
Male or female > 18 years of age;
Histologically or cytologically confirmed diagnosis of colorectal cancer
- Inclusion in the Target Population: Scheduled to receive at least 3 consecutive cycles of the same regimen of FOLFOX or FOLFIRI without monoclonal antibody;
- Inclusion in the Additional Population: Scheduled to receive at least 3 consecutive cycles of the same regimen of FOLFOX or FOLFIRI in combination with monoclonal antibody;
A performance status of ≤ 2 according to the Eastern Cooperative Oncology Group (ECOG) scale;
Non-childbearing female patient or female patient of childbearing potential using reliable contraceptive measures and having negative pregnancy test before treatment administration;
Able 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.

Exclusion Criteria:

Any investigational drugs within 30 days before enrollment or foreseen use of investigational agents during the study;
Treatment with chemotherapy of any type within 12 months before enrollment;
Patient with any type of ostomy (temporary ostomy should be closed at least 6 months prior to enrollment);
Patient who underwent total colectomy;
Patient who had abdominal-perineal resection or surgery leaving the patient without a functioning rectum;
Any radiotherapy to the abdomen or pelvis in the 6 months prior to enrollment;
Scheduled to receive radiotherapy to abdomen or pelvis during the study;
a) Exclusion from the Target population Scheduled to receive any concomitant chemotherapeutic agent, other than FOLFOX or FOLFIRI agents; 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;

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 Glucagon-like peptide-2 (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:

Aspartate aminotransferase (AST) ≥ 5 x upper limit of normal
Alanine aminotransferase (ALT) ≥ 5 x upper limit of normal
Bilirubin > 1.5 x upper limit of normal
Creatinine > 2 mg/dL (177 μmol/L)
Albumine < 2 g/dL (20 g/L)
Neutrophils < 1.5 x109/L
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 19 to 23 should be checked on Day 1 of Cycle 1. Exclusion criteria 7, 8, 9, 11 and 17 to 23 will be re-checked on Day 1 of Cycle 2.

Sites / Locations

State Institution "Republic Scientific and Practical Center of oncology and medical radiology n.a.N.N.Alexandrov"
Healthcare Institution Brest Regional Oncologic Dispensary
Institution Gomel Regional Clinical Oncology Dispensary
Healthcare Institution Minsk City Clinical Oncologic Dispensary
Healthcare Institution Mogilev Regional Oncologic Dispensary
Specialized Hospital for active treatment in oncology - Haskovo Ltd
''Multifunctional Hospital for Active Treatment Central Onco Hospital" Ltd
Complex Oncology Centre - Plovdiv Ltd
Multifunctional Hospital for Active Treatment for Women's Health Nadezhda Ltd.
"Specialized Hospital for Active Treatment of Oncology Diseases - Sofia city" EOOD
"Specialized Hospital for Active Treatment ofOncologal Diseases - Sofia District"
Pardubicka krajska nemocnice a.s
Klinikum Neuperlach
Semmelweis Egyetem, ÁOK I. Sz. Belgyógyászati Klinika, Onkológiai Részleg
Országos Onkológiai Intézet "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
Uzsoki Utcai Kórház Onkoradiológia, Sugárterápia, ővárosi Onkoradiológiai Központ
Debreceni Egyetem, OEC Onkológiai Tanszék
Somogy Megyei Kaposi Mór Oktató Kórház Klinikai Onkológiai Osztály
Jósa András Oktatókórház Onkoradiológiai Osztály
Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ Onkoterápiás Klinika
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház Onkológiai Osztály
Centrum Medyczne MrukMed
Wojewódzki Szpital Zespolony im. Rydygiera
Centrum Medyczne Malgorzata
State Budgetary Healthcare Institution of Republic of Mordovia "Republican Oncology Dispensary"
State Budgetary Healthcare Institution "Volgograd Regional Oncology Dispensary"
State Budgetary Institution of Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary"
Non-State Healthcare Institution "Railway Clinical Hospital at Chelyabinsk Station of Joint Stock Company "Russian Railways"
State Healthcare Institution "Kursk Regional Clinical Oncology Dispensary"
Federal State Budgetary Institution "Russian Oncology Scientific Centre named after N.N. Blokhin" of the Russian Academy of Medical Science
State Budgetary Healthcare Institution "City Clinical Hospital #40" of the Healthcare Department of Moscow
State Budgetary Healthcare Institution of Moscow "Moscow City Oncology Hospital #62" of Healthcare Department of Moscow
State Budgetary Healthcare Institution of Nizhny Novgorod region "Clinical Diagnostic centre"
State Budgetary Healthcare Institution of Nizhniy Novgorod Region "Nizhniy Novgorod Regional Oncology Dispensary"
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
Budgetary Healthcare Institution of Orel Region "Orel Oncology Dispensary"
State Budgetary Healthcare Institution "Orenburg Regional Clinical Oncology Dispensary"
State Budgetary Healthcare Institution of Perm Territory "Perm Territorial Oncology Dispensary"
State Budgetary Healthcare Institution of Stavropol Territory "Pyatigorsk Oncology Dispensary"
State Budgetary Educational Institution of Higher Professional Education "First Saint Petersburg State Medical University named after Academician I.P. Pavlov"
State Healthcare Institution "City Hospital #9" (Saint Petersburg Theoretical & Practical Centre of Coloproctology)
Research Institute of Pulmonology of State Budgetary Educational Institution of Higher Professional Education "First Saint Petersburg State Medical University named after Academician I.P. Pavlov" of the Ministry of Healthcare of the Russian Federation
State Budgetary Healthcare Institution "Saint Petersburg Clinical Theoretical & Practical Centre of Special Types of Medical Care (Oncology)"
State Budgetary Healthcare Institution "Samara Regional Clinical Oncology Dispensary" (Chemotherapy Unit #1)
State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary"
Chernigiv medical and prophylactic establishment "Chernigiv regional oncological center"
Communal Institution "Chernivtsi Regional clinical oncology dispensary"
Communal Institution Dnipropetrovsk City Multifunctional Clinical Hospital #4
Ivano-Frankivsk Regional Oncological Center
Communal Institution Kharkiv Regional Clinical Oncology Center
Municipal institution "Kirovograd Regional Oncology Center"
Regional Сommunal Institution Kryvyi Rig Oncology Dispensary
Kyiv City Clinical Oncological Center
Lviv State Oncological Regional Treatment and Preventive Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Elsiglutide 10 mg - target population

Elsiglutide 20 mg - target population

Elsiglutide 40 mg - target population

Placebo - target population

Elsiglutide 10 mg - additional population

Elsiglutide 20 mg - additional population

Elsiglutide 40 mg - additional population

Placebo - additional population

Arm Description

Elsiglutide 10 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy

Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving F-FU based chemotherapy

Elsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy

Placebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy

Elsiglutide 10 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.

Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.

Elsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.

Placebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.

Outcomes

Primary Outcome Measures

Proportion of patients experiencing a maximum Grade ≥ 2 diarrhea during the first cycle of chemotherapy in the target population

Secondary Outcome Measures

Proportion of patients experiencing a maximum Grade ≥ 2 diarrhea during the first cycle of chemotherapy in the additional population

Proportion of patients experiencing a maximum Grade ≥ 2 diarrhea during the second and third cycle of chemotherapy - target population

Proportion of patients experiencing a maximum Grade ≥ 2 diarrhea over the first two cycles of chemotherapy (i.e. in at least one of the first two cycles) - target population

Proportion of patients experiencing a maximum Grade 1, Grade 2, Grade 3, Grade 4, Grade 5 and any Grade (i.e. ≥ 1) diarrhea by cycle (Cycle 1, 2 and 3) - target population

Proportion of patients experiencing an overall Grade ≥ 2 diarrhea by cycle (Cycle 1, Cycle 2 and Cycle 3) - target population

Proportion of patients experiencing an overall Grade ≥ 2 diarrhea over the first two cycles of chemotherapy (i.e. in at least one of the first two cycles) - target population

Time to onset of first event of diarrhea of any Grade (i.e. ≥ 1) and time to onset of first event of diarrhea of Grade ≥ 2 (as assessed by the Investigator) by cycle (Cycle 1, 2 and 3) - target population

Time to first day with diarrhea (as reported by patient in the eDiary) by cycle (Cycle 1, 2 and 3) - target population

Cumulative duration (days) of any Grade (i.e. ≥ 1) diarrhea events and cumulative duration of Grade ≥ 2 diarrhea events (as assessed by the Investigator) by cycle (Cycle 1, 2 and 3) - target population

Cumulative duration (days) of diarrhea events (as assessed by the Investigator) by grade (Grade 1, Grade 2, Grade 3, Grade 4, Grade 5) and by cycle (Cycle 1, 2 and 3) - target population

Number of events of diarrhea by grade (as assessed by the Investigator) by cycle (Cycle 1, 2 and 3) - target population

Number of days with presence of diarrhea (as reported by patient in the eDiary) by cycle (Cycle 1, 2 and 3) - target population

Number of days with presence of at least one bowel movement with stools of consistency 6 or 7 (according to Bristol Stool Form Scale) accompanied by urgency or by fecal incontinence by cycle (Cycle 1, 2 and 3) - target population

Number of days with presence of abdominal discomfort by cycle (Cycle 1, 2 and 3) - target population

Number of days with limitation of self-care activities due to diarrhea by cycle (Cycle 1, 2 and 3) - target population

Proportion of patients: who required i.v. fluids due to CID, who required changes to the primary therapy due to CID, who used rescue medication (i.e. medication used for treatment of diarrhea) by cycle (Cycle 1, 2 and 3) - target population

Proportion of patients having a maximum Grade ≥ 2 diarrhea - shift from Cycle 1 to Cycle 2 and from Cycle 2 to Cycle 3 - target population

Proportion of patients having a maximum Grade ≥ 1 diarrhea - shift from Cycle 1 to Cycle 2 and from Cycle 2 to Cycle 3 - target population

Proportion of patients having an overall Grade ≥ 2 diarrhea - shift from Cycle 1 to Cycle 2 and from Cycle 2 to Cycle 3 - target population

Proportion of patients having an overall Grade ≥ 1 diarrhea - shift from Cycle 1 to Cycle 2 and from Cycle 2 to Cycle 3 - target population

Time trend of the citrulline plasma concentrations in Cycles 1, 2 and 3 - target population

Full Information

NCT ID

NCT02383810

First Posted

February 24, 2015

Last Updated

April 1, 2016

Sponsor

Helsinn Healthcare SA

Collaborators

Chiltern International Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02383810

Brief Title

Dose Finding Study in Colorectal Cancer Patients Receiving 5-FU-based Chemotherapy to Assess the Efficacy of Elsiglutide in the Prevention of Chemotherapy Induced Diarrhea (CID)

Official Title

Randomized, Double-blind, Parallel Group, Placebo-controlled, Dose Finding Study in Colorectal Cancer Patients Receiving 5-FU-based Chemotherapy to Assess the Efficacy of Different Doses of s.c. Elsiglutide in the Prevention of Chemotherapy Induced Diarrhea (CID)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Helsinn Healthcare SA

Collaborators

Chiltern International Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

This is a randomized, stratified, double-blind, double-dummy, parallel group, placebo-controlled, dose finding, multicentre, multinational, phase II study in patient with colorectal cancer receiving 5- Fluorouracil (5-FU)-based chemotherapy (FOLFOX -FOLinic acid, Fluorouracil, OXaliplatin chemotherapy regimen - or FOLFIRI - FOLinic acid, Fluorouracil, IRInotecan chemotherapy regimen). Patients will receive, starting from the day of chemotherapy administration, a single daily dose subcutaneously (s.c.) of elsiglutide 10, 20 or 40 mg or placebo for 4 consecutive days. Each patient will be in the study for 3 consecutive chemotherapy cycles. The treatment period for each patient will be 4 consecutive days at each of the first 2 chemotherapy cycles. Randomization will be performed with a 1:1:1:1 treatment allocation and will be stratified by chemotherapy regimen and country. Two populations are planned for this study. The population receiving FOLFOX or FOLFIRI without monoclonal antibody is defined as the Target population, while the population concomitantly receiving monoclonal antibody is defined as the Additional population. Randomization in Target and Additional population are handled independently. Primary Objective: To compare the efficacy of 3 s.c. doses of elsiglutide versus (vs.) placebo and vs. each other dose in the prevention of CID in colorectal cancer patients treated with 5-FU based chemotherapy (FOLFOX or FOLFIRI) with no addition of a monoclonal antibody. Secondary Objectives: As a secondary objective, the efficacy of 3 s.c. doses of elsiglutide vs. placebo and vs. each other dose in the prevention of CID in colorectal cancer patients treated with 5-FU based chemotherapy (FOLFOX or FOLFIRI) given in combination with a monoclonal antibody will be explored. Safety and tolerability of the administered repeated doses of elsiglutide will be evaluated. Additionally the following secondary objectives will be explored: The pharmacokinetics (PK) of elsiglutide, and its metabolites in each patient who consents to undergo an exposure assessment after the first administration and at steady state. The influence of possible demographic and therapeutic covariates on the PK parameters and their variability will also be investigated. The possible relationship between exposure of elsiglutide and its metabolites and efficacy measures in the target and overall population will be explored. The economic impact of the 3 doses of elsiglutide vs. placebo and each other dose in the treatment of CID. The impact on patient's QoL (quality of life) of the different dosages vs. placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug and/or Toxin-induced Diarrhea

Keywords

Chemotherapy Induced Diarrhea (CID)

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

498 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Elsiglutide 10 mg - target population

Arm Type

Active Comparator

Arm Description

Elsiglutide 10 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy

Arm Title

Elsiglutide 20 mg - target population

Arm Type

Active Comparator

Arm Description

Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving F-FU based chemotherapy

Arm Title

Elsiglutide 40 mg - target population

Arm Type

Active Comparator

Arm Description

Elsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy

Arm Title

Placebo - target population

Arm Type

Placebo Comparator

Arm Description

Placebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy

Arm Title

Elsiglutide 10 mg - additional population

Arm Type

Active Comparator

Arm Description

Elsiglutide 10 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.

Arm Title

Elsiglutide 20 mg - additional population

Arm Type

Active Comparator

Arm Description

Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.

Arm Title

Elsiglutide 40 mg - additional population

Arm Type

Active Comparator

Arm Description

Elsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.

Arm Title

Placebo - additional population

Arm Type

Placebo Comparator

Arm Description

Placebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.

Intervention Type

Drug

Intervention Name(s)

Elsiglutide

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Proportion of patients experiencing a maximum Grade ≥ 2 diarrhea during the first cycle of chemotherapy in the target population

Time Frame

15 days

Secondary Outcome Measure Information:

Title

Proportion of patients experiencing a maximum Grade ≥ 2 diarrhea during the first cycle of chemotherapy in the additional population

Time Frame

15 days

Title

Proportion of patients experiencing a maximum Grade ≥ 2 diarrhea during the second and third cycle of chemotherapy - target population

Time Frame

15 days of second and third cycle of chemotherapy

Title

Proportion of patients experiencing a maximum Grade ≥ 2 diarrhea over the first two cycles of chemotherapy (i.e. in at least one of the first two cycles) - target population

Time Frame

15 days of first and second cycle of chemotherapy

Title

Proportion of patients experiencing a maximum Grade 1, Grade 2, Grade 3, Grade 4, Grade 5 and any Grade (i.e. ≥ 1) diarrhea by cycle (Cycle 1, 2 and 3) - target population

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Proportion of patients experiencing an overall Grade ≥ 2 diarrhea by cycle (Cycle 1, Cycle 2 and Cycle 3) - target population

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Proportion of patients experiencing an overall Grade ≥ 2 diarrhea over the first two cycles of chemotherapy (i.e. in at least one of the first two cycles) - target population

Time Frame

15 days of first and second cycle of chemotherapy

Title

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Time to first day with diarrhea (as reported by patient in the eDiary) by cycle (Cycle 1, 2 and 3) - target population

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Cumulative duration (days) of diarrhea events (as assessed by the Investigator) by grade (Grade 1, Grade 2, Grade 3, Grade 4, Grade 5) and by cycle (Cycle 1, 2 and 3) - target population

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Number of events of diarrhea by grade (as assessed by the Investigator) by cycle (Cycle 1, 2 and 3) - target population

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Number of days with presence of diarrhea (as reported by patient in the eDiary) by cycle (Cycle 1, 2 and 3) - target population

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Number of days with presence of abdominal discomfort by cycle (Cycle 1, 2 and 3) - target population

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Number of days with limitation of self-care activities due to diarrhea by cycle (Cycle 1, 2 and 3) - target population

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Proportion of patients having a maximum Grade ≥ 2 diarrhea - shift from Cycle 1 to Cycle 2 and from Cycle 2 to Cycle 3 - target population

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Proportion of patients having a maximum Grade ≥ 1 diarrhea - shift from Cycle 1 to Cycle 2 and from Cycle 2 to Cycle 3 - target population

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Proportion of patients having an overall Grade ≥ 2 diarrhea - shift from Cycle 1 to Cycle 2 and from Cycle 2 to Cycle 3 - target population

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Proportion of patients having an overall Grade ≥ 1 diarrhea - shift from Cycle 1 to Cycle 2 and from Cycle 2 to Cycle 3 - target population

Time Frame

15 days of first, second and third cycle of chemotherapy

Title

Time trend of the citrulline plasma concentrations in Cycles 1, 2 and 3 - target population

Time Frame

15 days of first, second and third cycle of chemotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent Male or female > 18 years of age; Histologically or cytologically confirmed diagnosis of colorectal cancer Inclusion in the Target Population: Scheduled to receive at least 3 consecutive cycles of the same regimen of FOLFOX or FOLFIRI without monoclonal antibody; Inclusion in the Additional Population: Scheduled to receive at least 3 consecutive cycles of the same regimen of FOLFOX or FOLFIRI in combination with monoclonal antibody; A performance status of ≤ 2 according to the Eastern Cooperative Oncology Group (ECOG) scale; Non-childbearing female patient or female patient of childbearing potential using reliable contraceptive measures and having negative pregnancy test before treatment administration; Able 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. Exclusion Criteria: Any investigational drugs within 30 days before enrollment or foreseen use of investigational agents during the study; Treatment with chemotherapy of any type within 12 months before enrollment; Patient with any type of ostomy (temporary ostomy should be closed at least 6 months prior to enrollment); Patient who underwent total colectomy; Patient who had abdominal-perineal resection or surgery leaving the patient without a functioning rectum; Any radiotherapy to the abdomen or pelvis in the 6 months prior to enrollment; Scheduled to receive radiotherapy to abdomen or pelvis during the study; a) Exclusion from the Target population Scheduled to receive any concomitant chemotherapeutic agent, other than FOLFOX or FOLFIRI agents; 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; 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 Glucagon-like peptide-2 (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: Aspartate aminotransferase (AST) ≥ 5 x upper limit of normal Alanine aminotransferase (ALT) ≥ 5 x upper limit of normal Bilirubin > 1.5 x upper limit of normal Creatinine > 2 mg/dL (177 μmol/L) Albumine < 2 g/dL (20 g/L) Neutrophils < 1.5 x109/L 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 19 to 23 should be checked on Day 1 of Cycle 1. Exclusion criteria 7, 8, 9, 11 and 17 to 23 will be re-checked on Day 1 of Cycle 2.

Facility Information:

Facility Name

State Institution "Republic Scientific and Practical Center of oncology and medical radiology n.a.N.N.Alexandrov"

City

Lesnoy

State/Province

Minsk Region

ZIP/Postal Code

223040

Country

Belarus

Facility Name

Healthcare Institution Brest Regional Oncologic Dispensary

City

Brest

ZIP/Postal Code

224027

Country

Belarus

Facility Name

Institution Gomel Regional Clinical Oncology Dispensary

City

Gomel

ZIP/Postal Code

246012

Country

Belarus

Facility Name

Healthcare Institution Minsk City Clinical Oncologic Dispensary

City

Minsk

ZIP/Postal Code

220013

Country

Belarus

Facility Name

Healthcare Institution Mogilev Regional Oncologic Dispensary

City

Mogilev

ZIP/Postal Code

212018

Country

Belarus

Facility Name

Specialized Hospital for active treatment in oncology - Haskovo Ltd

City

Haskovo

ZIP/Postal Code

6300

Country

Bulgaria

Facility Name

''Multifunctional Hospital for Active Treatment Central Onco Hospital" Ltd

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Complex Oncology Centre - Plovdiv Ltd

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Multifunctional Hospital for Active Treatment for Women's Health Nadezhda Ltd.

City

Sofia

ZIP/Postal Code

1330

Country

Bulgaria

Facility Name

"Specialized Hospital for Active Treatment of Oncology Diseases - Sofia city" EOOD

City

Sofia

Country

Bulgaria

Facility Name

"Specialized Hospital for Active Treatment ofOncologal Diseases - Sofia District"

City

Sofia

Country

Bulgaria

Facility Name

Pardubicka krajska nemocnice a.s

City

Pardubice

ZIP/Postal Code

53203

Country

Czech Republic

Facility Name

Klinikum Neuperlach

City

München

ZIP/Postal Code

81737

Country

Germany

Facility Name

Semmelweis Egyetem, ÁOK I. Sz. Belgyógyászati Klinika, Onkológiai Részleg

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Országos Onkológiai Intézet "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Uzsoki Utcai Kórház Onkoradiológia, Sugárterápia, ővárosi Onkoradiológiai Központ

City

Budapest

ZIP/Postal Code

1145

Country

Hungary

Facility Name

Debreceni Egyetem, OEC Onkológiai Tanszék

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Somogy Megyei Kaposi Mór Oktató Kórház Klinikai Onkológiai Osztály

City

Kaposvár

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Jósa András Oktatókórház Onkoradiológiai Osztály

City

Nyíregyháza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ Onkoterápiás Klinika

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház Onkológiai Osztály

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Centrum Medyczne MrukMed

City

Rzeszów

ZIP/Postal Code

35-922

Country

Poland

Facility Name

Wojewódzki Szpital Zespolony im. Rydygiera

City

Toruń

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Centrum Medyczne Malgorzata

City

Śrem

ZIP/Postal Code

63-100

Country

Poland

Facility Name

State Budgetary Healthcare Institution of Republic of Mordovia "Republican Oncology Dispensary"

City

Saransk

State/Province

Republic of Mordovia

ZIP/Postal Code

430032

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution "Volgograd Regional Oncology Dispensary"

City

Volzhskiy

State/Province

Volgograd Region

ZIP/Postal Code

404130

Country

Russian Federation

Facility Name

State Budgetary Institution of Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary"

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Non-State Healthcare Institution "Railway Clinical Hospital at Chelyabinsk Station of Joint Stock Company "Russian Railways"

City

Chelyabinsk

ZIP/Postal Code

454091

Country

Russian Federation

Facility Name

State Healthcare Institution "Kursk Regional Clinical Oncology Dispensary"

City

Kursk

ZIP/Postal Code

305035

Country

Russian Federation

Facility Name

Federal State Budgetary Institution "Russian Oncology Scientific Centre named after N.N. Blokhin" of the Russian Academy of Medical Science

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution "City Clinical Hospital #40" of the Healthcare Department of Moscow

City

Moscow

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution of Moscow "Moscow City Oncology Hospital #62" of Healthcare Department of Moscow

City

Moscow

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution of Nizhny Novgorod region "Clinical Diagnostic centre"

City

Nizhniy Novgorod

ZIP/Postal Code

603006

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution of Nizhniy Novgorod Region "Nizhniy Novgorod Regional Oncology Dispensary"

City

Nizhniy Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

Budgetary Healthcare Institution of Orel Region "Orel Oncology Dispensary"

City

Orel

ZIP/Postal Code

302020

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution "Orenburg Regional Clinical Oncology Dispensary"

City

Orenburg

ZIP/Postal Code

460021

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution of Perm Territory "Perm Territorial Oncology Dispensary"

City

Perm

ZIP/Postal Code

614066

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution of Stavropol Territory "Pyatigorsk Oncology Dispensary"

City

Pyatigorsk

ZIP/Postal Code

357502

Country

Russian Federation

Facility Name

State Budgetary Educational Institution of Higher Professional Education "First Saint Petersburg State Medical University named after Academician I.P. Pavlov"

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

State Healthcare Institution "City Hospital #9" (Saint Petersburg Theoretical & Practical Centre of Coloproctology)

City

Saint Petersburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

Research Institute of Pulmonology of State Budgetary Educational Institution of Higher Professional Education "First Saint Petersburg State Medical University named after Academician I.P. Pavlov" of the Ministry of Healthcare of the Russian Federation

City

Saint Petersburg

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution "Saint Petersburg Clinical Theoretical & Practical Centre of Special Types of Medical Care (Oncology)"

City

Saint Petersburg

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution "Samara Regional Clinical Oncology Dispensary" (Chemotherapy Unit #1)

City

Samara

ZIP/Postal Code

443031

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary"

City

Ufa

ZIP/Postal Code

450054

Country

Russian Federation

Facility Name

Chernigiv medical and prophylactic establishment "Chernigiv regional oncological center"

City

Chernigiv

ZIP/Postal Code

14029

Country

Ukraine

Facility Name

Communal Institution "Chernivtsi Regional clinical oncology dispensary"

City

Chernivtsi

Country

Ukraine

Facility Name

Communal Institution Dnipropetrovsk City Multifunctional Clinical Hospital #4

City

Dnipropetrovsk

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

Ivano-Frankivsk Regional Oncological Center

City

Ivano-Frankivsk

ZIP/Postal Code

76000

Country

Ukraine

Facility Name

Communal Institution Kharkiv Regional Clinical Oncology Center

City

Kharkiv

ZIP/Postal Code

61070

Country

Ukraine

Facility Name

Municipal institution "Kirovograd Regional Oncology Center"

City

Kirovograd

ZIP/Postal Code

25011

Country

Ukraine

Facility Name

Regional Сommunal Institution Kryvyi Rig Oncology Dispensary

City

Kryvyi Rig

ZIP/Postal Code

50000

Country

Ukraine

Facility Name

Kyiv City Clinical Oncological Center

City

Kyiv

ZIP/Postal Code

03115

Country

Ukraine

Facility Name

Lviv State Oncological Regional Treatment and Preventive Center

City

Lviv

ZIP/Postal Code

79031

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

Dose Finding Study in Colorectal Cancer Patients Receiving 5-FU-based Chemotherapy to Assess the Efficacy of Elsiglutide in the Prevention of Chemotherapy Induced Diarrhea (CID)

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