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)

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2024
• Main ID: NCT02383810
• Date of registration: 24/02/2015
• Prospective Registration: No
• Primary sponsor: Helsinn Healthcare SA
• Public 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)
• Scientific 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)
• Date of first enrolment: January 2015
• Target sample size: 498
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02383810
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belarus, Bulgaria, Czech Republic, Czechia, Germany, Hungary, Poland, Russian Federation, Ukraine

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Written informed consent

2. Male or female > 18 years of age;

3. 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;

4. A performance status of = 2 according to the Eastern Cooperative Oncology Group (ECOG)
scale;

5. Non-childbearing female patient or female patient of childbearing potential using
reliable contraceptive measures and having negative pregnancy test before treatment
administration;

6. 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:

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 abdominal-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; 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Drug and/or Toxin-induced Diarrhea

Intervention(s)

Drug: Placebo

Drug: Elsiglutide

Primary Outcome(s)

Proportion of Patients Experiencing a Maximum Grade = 2 Diarrhea During the First Cycle of Chemotherapy in the Target Population [Time Frame: 15 days]

Secondary ID(s)

TIDE-13-22

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Chiltern International Inc.

Results

• Results available: Yes
• Date Posted: 01/03/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02383810