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)

NCT02383810 | Completed Phase 2 Results

• 1 other identifier: TIDE-13-22
• Study Type: interventional
• Target: 498
• Locations: 8 countries
• Sites: 54

Brief 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). 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.

Conditions

Drug and/or Toxin-induced Diarrhea

Keywords

Chemotherapy Induced Diarrhea (CID)

Outcome Measures

Primary Outcomes (1)

• 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.

  15 days

Study Arms (8)

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

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

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

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

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.

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.

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.

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.

Drug: Placebo

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Able to read, understand, follow the study procedure and complete patient diary.

You may not qualify if:

• 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;
• \. 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;
• \. History of chronic (≥ 30 consecutive days) use of laxatives;
• \. Active and ongoing systemic infection;
• \. Lactating woman;
• \. History of hypersensitivity or allergies to drugs or compounds potentially related to this investigational drug class;
• \. Previous exposure to Glucagon-like peptide-2 (GLP-2) or other compounds in this investigational drug class;
• \. Patient who participated in a previous study with elsiglutide;
• \. Patient with abnormalities in selected laboratory parameters, including:

Sponsors & Collaborators

• Helsinn Healthcare SA: lead
• Chiltern International Inc.: collaborator

Study Sites (54)

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

Lyasny, Minsk Oblast, 223040, Belarus

Location

Healthcare Institution Brest Regional Oncologic Dispensary

Brest, 224027, Belarus

Location

Institution Gomel Regional Clinical Oncology Dispensary

Homyel, 246012, Belarus

Location

Healthcare Institution Minsk City Clinical Oncologic Dispensary

Minsk, 220013, Belarus

Location

Healthcare Institution Mogilev Regional Oncologic Dispensary

Mogilev, 212018, Belarus

Location

Specialized Hospital for active treatment in oncology - Haskovo Ltd

Haskovo, 6300, Bulgaria

Location

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

Plovdiv, 4000, Bulgaria

Location

Complex Oncology Centre - Plovdiv Ltd

Plovdiv, 4000, Bulgaria

Location

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

Sofia, 1330, Bulgaria

Location

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

Sofia, Bulgaria

Location

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

Sofia, Bulgaria

Location

Pardubicka krajska nemocnice a.s

Pardubice, 53203, Czechia

Location

Klinikum Neuperlach

München, 81737, Germany

Location

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

Budapest, 1083, Hungary

Location

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

Budapest, 1122, Hungary

Location

Uzsoki Utcai Kórház Onkoradiológia, Sugárterápia, ővárosi Onkoradiológiai Központ

Budapest, 1145, Hungary

Location

Debreceni Egyetem, OEC Onkológiai Tanszék

Debrecen, 4032, Hungary

Location

Somogy Megyei Kaposi Mór Oktató Kórház Klinikai Onkológiai Osztály

Kaposvár, 7400, Hungary

Location

Jósa András Oktatókórház Onkoradiológiai Osztály

Nyíregyháza, 4400, Hungary

Location

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

Szeged, 6720, Hungary

Location

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház Onkológiai Osztály

Szolnok, 5000, Hungary

Location

Centrum Medyczne Malgorzata

Gmina Śrem, 63-100, Poland

Location

Centrum Medyczne MrukMed

Rzeszów, 35-922, Poland

Location

Wojewódzki Szpital Zespolony im. Rydygiera

Torun, 87-100, Poland

Location

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

Saransk, Respublika Mordoviya, 430032, Russia

Location

State Budgetary Healthcare Institution "Volgograd Regional Oncology Dispensary"

Volzhsky, Volgograd Oblast, 404130, Russia

Location

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

Arkhangelsk, 163045, Russia

Location

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

Chelyabinsk, 454091, Russia

Location

State Healthcare Institution "Kursk Regional Clinical Oncology Dispensary"

Kursk, 305035, Russia

Location

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

Moscow, 115478, Russia

Location

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

Moscow, Russia

Location

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

Moscow, Russia

Location

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

Nizhny Novgorod, 603006, Russia

Location

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

Nizhny Novgorod, 603126, Russia

Location

Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"

Omsk, 644013, Russia

Location

State Budgetary Healthcare Institution "Orenburg Regional Clinical Oncology Dispensary"

Orenburg, 460021, Russia

Location

Budgetary Healthcare Institution of Orel Region "Orel Oncology Dispensary"

Oryol, 302020, Russia

Location

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

Perm, 614066, Russia

Location

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

Pyatigorsk, 357502, Russia

Location

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

Saint Petersburg, 197022, Russia

Location

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

Saint Petersburg, 197110, Russia

Location

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, Russia

Location

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

Saint Petersburg, Russia

Location

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

Samara, 443031, Russia

Location

State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary"

Ufa, 450054, Russia

Location

Chernigiv medical and prophylactic establishment "Chernigiv regional oncological center"

Chernihiv, 14029, Ukraine

Location

Communal Institution "Chernivtsi Regional clinical oncology dispensary"

Chernivtsi, Ukraine

Location

Communal Institution Dnipropetrovsk City Multifunctional Clinical Hospital #4

Dnipropetrovsk, 49102, Ukraine

Location

Ivano-Frankivsk Regional Oncological Center

Ivano-Frankivsk, 76000, Ukraine

Location

Communal Institution Kharkiv Regional Clinical Oncology Center

Kharkiv, 61070, Ukraine

Location

Municipal institution "Kirovograd Regional Oncology Center"

Kropyvnytskyi, 25011, Ukraine

Location

Regional Сommunal Institution Kryvyi Rig Oncology Dispensary

Kryvyi Rih, 50000, Ukraine

Location

Kyiv City Clinical Oncological Center

Kyiv, 03115, Ukraine

Location

Lviv State Oncological Regional Treatment and Preventive Center

Lviv, 79031, Ukraine

Location

Results Point of Contact

• Title: Director of Clinical Division
• Organization: Helsinn Healthcare SA

info@helsinn.com

+41 91 9852121

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 9, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 1, 2024
• Results First Posted: March 1, 2024

Record last verified: 2024-02

Locations

PL (3); RU (21); BE (5); BU (6); DE (1); UA (9); HU (8); CZ (1)