A Phase 2 interventional study of Elsiglutide and Placebo in Drug and/or Toxin-induced Diarrhea, sponsored by Helsinn Healthcare SA. Completed at 54 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Helsinn Healthcare SA · Phase 2, Interventional, and Prevention
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 or FOLFIRI). 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.
The primary objective is 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.
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:
Additionally the following secondary objectives will be explored:
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's enrollment of 498 is above the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Helsinn Healthcare SA is the lead sponsor of 32 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
or cytologically confirmed diagnosis of colorectal cancer
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:
count \< 100 x109/L ;
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Elsiglutide 10 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy
Drug: Elsiglutide
Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving F-FU based chemotherapy
Drug: Elsiglutide
Elsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy
Drug: Elsiglutide
Placebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy
Drug: Placebo
Elsiglutide 10 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.
Drug: Elsiglutide
Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.
Drug: Elsiglutide
Elsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.
Drug: Elsiglutide
Placebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.
Drug: Placebo
Proportion of Patients Experiencing a Maximum Grade ≥ 2 Diarrhea During the First Cycle of Chemotherapy in the Target Population
The endpoint of primary interest for efficacy was the proportion of patients within the Target population experiencing a maximum Grade ≥ 2 diarrhea in Cycle 1 (as assessed by the Investigator). For patient 8031362 who withdrew consent after 11 day in Cycle 1, Investigator assessments for the individual diarrhea events were missing. The data were imputed as Grade 0 for the primary endpoint, in line with the patient's eDiary data. Additional population is not included in primary endpoint evaluation.
Time frame: 15 days
| Milestone | 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 |
|---|---|---|---|---|---|---|---|---|
| Started | 120 | 122 | 120 | 123 | 4 | 4 | 3 | 2 |
| Completed | 117 | 114 | 113 | 112 | 4 | 3 | 2 | 2 |
| Not completed | 3 | 8 | 7 | 11 | 0 | 1 | 1 | 0 |
| Withdrew: Physician decision | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 3 | 3 | 3 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 2 | 4 | 5 | 0 | 1 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Other | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Withdrew: Subject did not receive study treatment | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
The endpoint of primary interest for efficacy was the proportion of patients within the Target population experiencing a maximum Grade ≥ 2 diarrhea in Cycle 1 (as assessed by the Investigator). For patient 8031362 who withdrew consent after 11 day in Cycle 1, Investigator assessments for the individual diarrhea events were missing. The data were imputed as Grade 0 for the primary endpoint, in line with the patient's eDiary data. Additional population is not included in primary endpoint evaluation.
| percentage of patients | Elsiglutide 10 mg - Target Population | Elsiglutide 20 mg - Target Population | Elsiglutide 40 mg - Target Population | Placebo - Target Population |
|---|---|---|---|---|
| With maximum Grade ≥ 2 diarrhea | 2.5 | 5.0 | 5.8 | 9.8 |
| With maximum Grade < 2 diarrhea | 97.5 | 95.0 | 94.2 | 90.2 |
Collected over AEs were collected from signature of Informed Consent until End of Trial visit (Day 14 after start of last cycle). Duration of collection was 7-8 weeks for each patient.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Elsiglutide 10 mg - Overall Set | 1/124 (0.8%) | 2/124 (1.6%) | 71/124 (57.3%) |
| Elsiglutide 20 mg - Overall | 1/125 (0.8%) | 4/125 (3.2%) | 68/125 (54.4%) |
| Elsiglutide 40 mg - Overall | 2/123 (1.6%) | 3/123 (2.4%) | 73/123 (59.3%) |
| Placebo - Overall | 3/125 (2.4%) | 6/125 (4.8%) | 72/125 (57.6%) |
| Event | Elsiglutide 10 mg - Overall Set | Elsiglutide 20 mg - Overall | Elsiglutide 40 mg - Overall | Placebo - Overall |
|---|---|---|---|---|
| Disease progressionGeneral disorders | 0/124 | 0/125 | 0/123 | 2/125 |
| Hypovolaemic shockVascular disorders | 0/124 | 0/125 | 1/123 | 0/125 |
| DeathGeneral disorders | 0/124 | 0/125 | 1/123 | 0/125 |
| Intestinal obstructionGastrointestinal disorders | 1/124 | 1/125 | 1/123 | 0/125 |
| Supraventricular tachycardiaCardiac disorders | 1/124 | 0/125 | 0/123 | 0/125 |
| Abdominal abscessInfections and infestations | 1/124 | 0/125 | 0/123 | 0/125 |
| Septic shockInfections and infestations | 1/124 | 0/125 | 0/123 | 0/125 |
| Thrombophlebitis superficialVascular disorders | 0/124 | 0/125 | 0/123 | 1/125 |
| Electrocardiogram T wave inversionInvestigations | 0/124 | 1/125 | 0/123 | 0/125 |
| Cardiac arrestCardiac disorders | 0/124 | 1/125 | 0/123 | 1/125 |
| Event | Elsiglutide 10 mg - Overall Set | Elsiglutide 20 mg - Overall | Elsiglutide 40 mg - Overall | Placebo - Overall |
|---|---|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 32/124 | 29/125 | 26/123 | 32/125 |
| NauseaGastrointestinal disorders | 21/124 | 17/125 | 15/123 | 17/125 |
| LeukopeniaBlood and lymphatic system disorders | 6/124 | 10/125 | 6/123 | 12/125 |
| Abdominal tendernessGastrointestinal disorders | 0/124 | 11/125 | 7/123 | 7/125 |
| Injection site erythemaGeneral disorders | 1/124 | 3/125 | 10/123 | 0/125 |
| AstheniaGeneral disorders | 9/124 | 8/125 | 7/123 | 7/125 |
| AnaemiaBlood and lymphatic system disorders | 6/124 | 7/125 | 7/123 | 9/125 |
| VomitingGastrointestinal disorders | 1/124 | 3/125 | 7/123 | 5/125 |
The full analysis set (FAS) was defined as all randomized patients who received at least 1 dose of study medication (elsiglutide or placebo) and (at least part of) the chemotherapy regimen in Cycle 1. The FAS Target set was defined as all patients from the Target population who were eligible for the FAS.
| Age, Continuous(years) | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 58.3 ± 10.42 | 59.0 ± 10.84 | 60.6 ± 8.44 | 61.9 ± 9.57 | 62.0 ± 8.76 | 55.8 ± 12.53 | 57.7 ± 4.04 | 57.0 ± 7.07 | 61 ± 9.88 |
| Sex: Female, Male(Participants) | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 54 | 62 | 51 | 59 | 3 | 1 | 2 | 0 | 232 |
| Male | 66 | 59 | 69 | 64 | 1 | 3 | 1 | 2 | 265 |
| Race (NIH/OMB)(Participants) | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 118 | 120 | 117 | 123 | 4 | 4 | 3 | 2 | 491 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 5 |
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