Chemotherapy Induced Diarrhea MedDRA version: 14.1 Level: LLT Classification code 10057013 Term: Diarrhea post chemotherapy System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: Elsiglutide
Product Code: ZP1846
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: elsiglutide
Current Sponsor code: ZP1846
Other descriptive name: H-His-Gly-Gl
Sponsors
Helsinn Healthcare SA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of patients experiencing Grades =2 diarrhea (NCI-CTCAE v. 4.0) from Day 1 to Day 14; 2. Worst grade of diarrhea according to NCI-CTCAE v. 4.0 (from Day 1 to Day 14); 3. Time to occurrence of diarrhea, defined as the first day in which a Grade = 1 diarrhea is assessed (from Day 1 to day 14); 4. Number of days with presence of Grade = 1 diarrhea (from Day 1 to Day 14); 5. Number of days with presence of Grade = 2 diarrhea (from Day 1 to Day 14); 6. Number of days with presence of at least one bowel movement accompanied by urgency (from Day 1 to 14); 7. Number of days with presence of at least one episode of fecal incontinence (from Day 1 to 14); 8. Proportion of patients who required i.v. fluids due to CID (from Day 1 to 14); 9. Proportion of patients who required changes to the primary therapy (chemotherapy dose reduction, delay or change to regimen) due to CID as of Day 2, Day 14 and as of Day 28; 10. Proportion of patients who use rescue medication (i.e. medication used for treatment of diarrhea) from Day 1 to Day 14.;Timepoint(s) of evaluation of this end point: Day 1 to Day 14, on a daily basis (except for secondary endpoint 9 which has to be performed at Day 28 as well). | — |
Countries
Bulgaria, Hungary, Romania, Russian Federation
Contacts
Public ContactRegulatory Affairs
PSI CRO Hungary Pharma Support LLC
Outcome results
None listed