Drug and/or Toxin-induced DiarrheaPhase 2NCT02383810
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)
A Phase 2 study testing Elsiglutide in people with Drug and/or Toxin-induced Diarrhea, run by Helsinn Healthcare SA at 54 sites in 8 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug and/or Toxin-induced Diarrhea
- What is being tested?
- Elsiglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 498 participants
- Where
- 54 sitesin 8 countries
- Study dates
- Jan 2015to Feb 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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;
Show all 32Show fewer
- 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.
Trial locations and contacts
54 sites in 8 countries.
54 sites in 8 countries
Russia21 sites
State Budgetary Institution of Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary"
Arkhangelsk, 163045
Non-State Healthcare Institution "Railway Clinical Hospital at Chelyabinsk Station of Joint Stock Company "Russian Railways"
Chelyabinsk, 454091
State Healthcare Institution "Kursk Regional Clinical Oncology Dispensary"
Kursk, 305035
Federal State Budgetary Institution "Russian Oncology Scientific Centre named after N.N. Blokhin" of the Russian Academy of Medical Science
Moscow, 115478
State Budgetary Healthcare Institution "City Clinical Hospital #40" of the Healthcare Department of Moscow
Moscow
State Budgetary Healthcare Institution of Moscow "Moscow City Oncology Hospital #62" of Healthcare Department of Moscow
Moscow
State Budgetary Healthcare Institution of Nizhny Novgorod region "Clinical Diagnostic centre"
Nizhny Novgorod, 603006
State Budgetary Healthcare Institution of Nizhniy Novgorod Region "Nizhniy Novgorod Regional Oncology Dispensary"
Nizhny Novgorod, 603126
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
Omsk, 644013
State Budgetary Healthcare Institution "Orenburg Regional Clinical Oncology Dispensary"
Orenburg, 460021
Budgetary Healthcare Institution of Orel Region "Orel Oncology Dispensary"
Oryol, 302020
State Budgetary Healthcare Institution of Perm Territory "Perm Territorial Oncology Dispensary"
Perm, 614066
State Budgetary Healthcare Institution of Stavropol Territory "Pyatigorsk Oncology Dispensary"
Pyatigorsk, 357502
State Budgetary Educational Institution of Higher Professional Education "First Saint Petersburg State Medical University named after Academician I.P. Pavlov"
Saint Petersburg, 197022
State Healthcare Institution "City Hospital #9" (Saint Petersburg Theoretical & Practical Centre of Coloproctology)
Saint Petersburg, 197110
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
Saint Petersburg
State Budgetary Healthcare Institution "Saint Petersburg Clinical Theoretical & Practical Centre of Special Types of Medical Care (Oncology)"
Saint Petersburg
State Budgetary Healthcare Institution "Samara Regional Clinical Oncology Dispensary" (Chemotherapy Unit #1)
Samara, 443031
State Budgetary Healthcare Institution of Republic of Mordovia "Republican Oncology Dispensary"
Saransk, Respublika Mordoviya, 430032
State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary"
Ufa, 450054
State Budgetary Healthcare Institution "Volgograd Regional Oncology Dispensary"
Volzhsky, Volgograd Oblast, 404130
Ukraine9 sites
Chernigiv medical and prophylactic establishment "Chernigiv regional oncological center"
Chernihiv, 14029
Communal Institution "Chernivtsi Regional clinical oncology dispensary"
Chernivtsi
Communal Institution Dnipropetrovsk City Multifunctional Clinical Hospital #4
Dnipropetrovsk, 49102
Ivano-Frankivsk Regional Oncological Center
Ivano-Frankivsk, 76000
Communal Institution Kharkiv Regional Clinical Oncology Center
Kharkiv, 61070
Municipal institution "Kirovograd Regional Oncology Center"
Kropyvnytskyi, 25011
Regional Сommunal Institution Kryvyi Rig Oncology Dispensary
Kryvyi Rih, 50000
Kyiv City Clinical Oncological Center
Kyiv, 03115
Lviv State Oncological Regional Treatment and Preventive Center
Lviv, 79031
Hungary8 sites
Semmelweis Egyetem, ÁOK I. Sz. Belgyógyászati Klinika, Onkológiai Részleg
Budapest, 1083
Országos Onkológiai Intézet "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
Budapest, 1122
Uzsoki Utcai Kórház Onkoradiológia, Sugárterápia, ővárosi Onkoradiológiai Központ
Budapest, 1145
Debreceni Egyetem, OEC Onkológiai Tanszék
Debrecen, 4032
Somogy Megyei Kaposi Mór Oktató Kórház Klinikai Onkológiai Osztály
Kaposvár, 7400
Jósa András Oktatókórház Onkoradiológiai Osztály
Nyíregyháza, 4400
Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ Onkoterápiás Klinika
Szeged, 6720
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház Onkológiai Osztály
Szolnok, 5000
Bulgaria6 sites
Specialized Hospital for active treatment in oncology - Haskovo Ltd
Haskovo, 6300
''Multifunctional Hospital for Active Treatment Central Onco Hospital" Ltd
Plovdiv, 4000
Complex Oncology Centre - Plovdiv Ltd
Plovdiv, 4000
Multifunctional Hospital for Active Treatment for Women's Health Nadezhda Ltd.
Sofia, 1330
"Specialized Hospital for Active Treatment of Oncology Diseases - Sofia city" EOOD
Sofia
"Specialized Hospital for Active Treatment ofOncologal Diseases - Sofia District"
Sofia
Belarus5 sites
Healthcare Institution Brest Regional Oncologic Dispensary
Brest, 224027
Institution Gomel Regional Clinical Oncology Dispensary
Homyel, 246012
State Institution "Republic Scientific and Practical Center of oncology and medical radiology n.a.N.N.Alexandrov"
Lyasny, Minsk Oblast, 223040
Healthcare Institution Minsk City Clinical Oncologic Dispensary
Minsk, 220013
Healthcare Institution Mogilev Regional Oncologic Dispensary
Mogilev, 212018
Poland3 sites
Centrum Medyczne Malgorzata
Gmina Śrem, 63-100
Centrum Medyczne MrukMed
Rzeszów, 35-922
Wojewódzki Szpital Zespolony im. Rydygiera
Torun, 87-100
About this study
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)
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.
Read the 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.
- Conditions
- Drug and/or Toxin-induced Diarrhea
- Being tested
- Elsiglutide, Placebo
- Keywords
- Chemotherapy Induced Diarrhea (CID)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElsiglutideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Elsiglutide 10 mg - target population | Active comparator | Elsiglutide 10 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy Receives: Drug: Elsiglutide |
| Elsiglutide 20 mg - target population | Active comparator | Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving F-FU based chemotherapy Receives: Drug: Elsiglutide |
| Elsiglutide 40 mg - target population | Active comparator | Elsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy Receives: Drug: Elsiglutide |
| Placebo - target population | Placebo comparator | Placebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy Receives: Drug: Placebo |
| Elsiglutide 10 mg - additional population | Active comparator | Elsiglutide 10 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. Receives: Drug: Elsiglutide |
| Elsiglutide 20 mg - additional population | Active comparator | Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. Receives: Drug: Elsiglutide |
| Elsiglutide 40 mg - additional population | Active comparator | Elsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. Receives: Drug: Elsiglutide |
| Placebo - additional population | Placebo comparator | Placebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Drug and/or Toxin-induced DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinn Healthcare SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chiltern International Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383810
- Sponsor's protocol ID
- TIDE-13-22
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2015
- Last updated
- 1 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02383810
- Acronym / sponsor ID
- TIDE-13-22
- Conditions
- Drug and/or Toxin-induced Diarrhea
- Keywords
- Chemotherapy Induced Diarrhea (CID)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Helsinn Healthcare SAIndustry (pharma, biotech, devices)
- Collaborators
- Chiltern International Inc.
- Study start
- Jan 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Posted 1 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Elsiglutide 10 mg - target population | Active comparator | Drug: ElsiglutideElsiglutide 10 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy |
| Elsiglutide 20 mg - target population | Active comparator | Drug: ElsiglutideElsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving F-FU based chemotherapy |
| Elsiglutide 40 mg - target population | Active comparator | Drug: ElsiglutideElsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy |
| Placebo - target population | Placebo comparator | Drug: PlaceboPlacebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy |
| Elsiglutide 10 mg - additional population | Active comparator | Drug: ElsiglutideElsiglutide 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 - additional population | Active comparator | Drug: ElsiglutideElsiglutide 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 - additional population | Active comparator | Drug: ElsiglutideElsiglutide 40 mg once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. |
| Placebo - additional population | Placebo comparator | Drug: PlaceboPlacebo once daily as s.c. injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent
- Male or female > 18 years of age;
- Histologically or cytologically confirmed diagnosis of colorectal cancer
- 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;
Key exclusion criteria (32 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elsiglutide | Drug | Elsiglutide 10 mg - additional population, Elsiglutide 10 mg - target population, Elsiglutide 20 mg - additional population, Elsiglutide 20 mg - target population, Elsiglutide 40 mg - additional population, Elsiglutide 40 mg - target population |
| Placebo | Drug | Placebo - additional population, Placebo - target population |
Primary outcome
Proportion of Patients Experiencing a Maximum Grade ≥ 2 Diarrhea During the First Cycle of Chemotherapy in the Target Population
Time frame: 15 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
54 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elsiglutide in people with Drug and/or Toxin-induced Diarrhea, run by Helsinn Healthcare SA at 54 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Russia, Ukraine, Hungary, Bulgaria, Belarus and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Experiencing a Maximum Grade ≥ 2 Diarrhea During the First Cycle of Chemotherapy in the Target Population (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.