DiarrheaPhase 2NCT01543451
Proof-of-Concept Study in Cancer Patients to Assess Efficacy of Elsiglutide in Preventing Chemotherapy-Induced Diarrhea
A Phase 2 study testing Elsiglutide in people with Diarrhea, run by Helsinn Healthcare SA at 21 sites in 4 countries.
Trial summary
The main objective of this study will be to obtain data on the efficacy of elsiglutide in preventing Chemotherapy Induced Diarrhea (CID) in patients with colorectal cancer receiving 5-FU based chemotherapy (FOLFOX4 or FOLFIRI regimen) in comparison to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea
- What is being tested?
- Elsiglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 21 sitesin 4 countries
- Study dates
- Feb 2012to Oct 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 patient ≥ 18 years of age;
- Confirmed diagnosis of colorectal cancer;
- Chemotherapy naïve patient;
- Patient scheduled to receive a FOLFOX4 or FOLFIRI chemotherapy regimen according to the following scheme and dosage (1st cycle):
- AGENT DOSE ROUTE/DURATION DAYS Oxaliplatin or Irinotecan 85/180 mg m2 i.v. infusion/2h 1 FolinicAcid (leucovorin) 200 mg m2 i.v. infusion/2h 1+2 5-Fluorouracil (5FU) 400 mg m2 i.v. bolus 1+2 5-Fluorouracil (5FU) 600 mg m2 i.v. infusion/22h 1+2
Show all 9Show fewer
- A performance status of ≤ 2 according to the Eastern Cooperative Oncology Group(ECOG);
- Non-fertile patient or fertile patient (male or female) using reliable contraceptive measures
- Female patient of childbearing potential; need to have a negative pregnancy test at screening.
Who cannot join
- Inability to understand study procedures and/or cooperate with the study Investigator;
- Any investigational drugs within 30 days before enrollment in the study or foreseen use of investigational agents during the study;
- Patient with any type of ostomy;
- Any previous radiotherapy to the abdomen or pelvis;
- Scheduled to receive radiotherapy to abdomen or pelvis during the study (Day 1 to Day 14);
- 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;
Show all 30Show fewer
- Previous use or scheduled to receive monoclonal antibodies (e.g. bevacizumab, cetuximab, etc) during the study (From Day 1 to Day 14);
- Major surgery within the previous 3 weeks;
- 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;
- Any diarrhea in the 48 hours preceding study drug administration;
- Use of anti-diarrheal agents within the 48 hours prior to study drug administration;
- Use of laxatives within 7 days prior to study drug administration;
- Use of antibiotics within 7 days prior to study drug administration;
- 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 GLP-2 or other compounds in this investigational drug class;
- Abnormal laboratory values, including
- Aspartate aminotransferase (AST) ≥ 5 x upper limit of normal
- Alanine aminotransferase (ALT) ≥ 5 x upper limit of normal
- Bilirubin > 2 mg/dL (34 μmol/L)
- Creatinine > 2 mg/dL (177 μmol/L)
- Albumine < 2 g/dL (20 g/L)
- Neutrophils< 1.5 x109/L
- Platelet count < 100 x109/L;
- Concomitant bleeding disorders;
- Other serious concomitant illness, which could interfere with the study;
- Patient who participated in a previous study with elsiglutide (ZP1846).
- Exclusion criteria 1-9 and 12-22 will be verified at screening. Exclusion criteria 10 and 11 will be checked on Day 1 only. Exclusion criteria 12, 13 and 15 will be re-checked on Day 1.
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
Russia7 sites
Regional Oncology Center
Arkhangelsk, Arkhangelskaya oblast, 163045
Kursk Regional Clinical Oncology Center
Kursk, Kursk Oblast, 305035
Pyatigorsk Oncology Center
Pyatigorsk, Pyatigorsk, 357502
City #9 Hospital
Saint Petersburg, Sankt-Peterburg, 197110
City Clinical Oncology Center
Saint Petersburg, Sankt-Peterburg, 198255
Regional Clinical Oncology Center - Chemotherapy Department
Ulyanovsk, Ulyanovsk Oblast, 432063
Regional Oncology Hospital
Yaroslavl, Yaroslavl Oblast, 150054
Bulgaria5 sites
Department of Chemotherapy, Complex Oncology Center
Rousse, Ruse, 7002
Chemotherapy Department, Complex Oncology Center
Shumen, Shumen, 9700
Department of Chemotherapy Specialized Hospital for Active Treatment of Oncological Diseases
Sofia, Sofia, 1233
Department of Chemotherapy Specialized Hospital for Active Treatment of Oncological Diseases
Sofia, Sofia, 1784
Oncology Clinic, Multiprofile Hospital for Active Treatment "Sveta Marina"
Varna, Varna, 9010
Romania5 sites
Dr. Constantin Opris Clinical Country Emergency Hospital Baia Mare, Department of Oncology
Baia Mare, Maramureş, 430031
Fundeni Clinical Institute - Medical Oncology Department
Bucharest, Bucharest, 022328
Prof. Dr. Ion Chiricuta Institute of Oncology, Medical Oncology Department
Cluj-Napoca, Cluj, 400015
Euroclinic Oncology Center SRL - Medical Oncology Department
Iași, Iaşi, 700106
Sf. Ioan cel Nou Emergency Clincal County Hospital
Suceava, Suceava, 720237
Hungary4 sites
Semmelweis University, Department of Diagnostic Radiology and Oncotherapy
Budapest, Budapest, H-1082
Kenezy Hospital, Department of Clinical Pharmacology, Infectology and Allergology
Debrecen, Debrecen, H-4043
Petz Aladar County Teaching Hospital, Center of Oncologic Radiology Hungary
Győr, Hungary, 9024
Szeged Medical University Department of Oncology and Oncotherapy
Szeged, Szeged, H-6720
About this study
Official title: Phase II, Double-blind, Randomized, Two-stage, Placebo-controlled Proof of Concept Study in Colorectal Cancer Patients Receiving 5-FU Based Chemotherapy to Assess the Efficacy of Elsiglutide (ZP1846)Administered s.c. in the Prevention of Chemotherapy Induced Diarrhea(CID)
The main objective of this study will be to obtain data on the efficacy of elsiglutide in preventing Chemotherapy Induced Diarrhea (CID) in patients with colorectal cancer receiving 5-FU based chemotherapy (FOLFOX4 or FOLFIRI regimen) in comparison to placebo.
- Conditions
- Diarrhea
- Being tested
- Elsiglutide, Placebo
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElsiglutideDrug
24 mg administered s.c. once daily for 4 consecutive days from Day 1 chemotherapy
PlaceboDrug
24 mg administered s.c. once daily for 4 consecutive days from Day 1 chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Elsiglutide | Experimental | Not described Receives: Drug: Elsiglutide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients experiencing Diarrhea
Severity of Diarrhea will be classified according to the NCI-CTCAE.
Measured: Day 1 to Day 14
Secondary outcomes (2)
Safety and tolerability of the administered repeated doses of elsiglutide (ZP1846) will be evaluated
Safety will be evaluated by monitoring:
- Physical examination
- Vital signs
- Clinical laboratory parameters (hematology, blood chemistry, urinalysis)
- 12-lead ECG
- AEs
- Immunogenicity testing in a subset of patients
Measured: Day 1 to Day 32
PK of elsiglutide will be evaluated
The followin standard PK parameters will be evaluated:
Tmax, Cmax, AUC0-t, AUC0-24, AUC0-∞, t1/2Z, λZ, CL/F, VZ/F, the effect of multiple dosing will be evaluated (accumulation ratio). Blood sampling for PK will be performed at: pre-dose, 2h, 4, 6, 12, 24 h post-dose
Measured: Day 1 to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinn Healthcare SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543451
- Sponsor's protocol ID
- TIDE-11-10
- Status last verified
- Feb 2014
- First submitted
- 21 Feb 2012
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Double-blind, Randomized, Two-stage, Placebo-controlled Proof of Concept Study in Colorectal Cancer Patients Receiving 5-FU Based Chemotherapy to Assess the Efficacy of Elsiglutide (ZP1846)Administered s.c. in the Prevention of Chemotherapy Induced Diarrhea(CID)
- ClinicalTrials.gov ID
- NCT01543451
- Acronym / sponsor ID
- TIDE-11-10
- Conditions
- Diarrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Helsinn Healthcare SAIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study will be to obtain data on the efficacy of elsiglutide in preventing Chemotherapy Induced Diarrhea (CID) in patients with colorectal cancer receiving 5-FU based chemotherapy (FOLFOX4 or FOLFIRI regimen) in comparison to placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elsiglutide | Experimental | Drug: Elsiglutide |
| Placebo | Placebo comparator | Drug: Placebo |
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 patient ≥ 18 years of age;
- Confirmed diagnosis of colorectal cancer;
- Chemotherapy naïve patient;
- Patient scheduled to receive a FOLFOX4 or FOLFIRI chemotherapy regimen according to the following scheme and dosage (1st cycle):
Key exclusion criteria (30 listed)
- Inability to understand study procedures and/or cooperate with the study Investigator;
- Any investigational drugs within 30 days before enrollment in the study or foreseen use of investigational agents during the study;
- Patient with any type of ostomy;
- Any previous radiotherapy to the abdomen or pelvis;
- Scheduled to receive radiotherapy to abdomen or pelvis during the study (Day 1 to Day 14);
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 |
|---|---|---|
| Elsiglutide24 mg administered s.c. once daily for 4 consecutive days from Day 1 chemotherapy | Drug | Elsiglutide |
| Placebo24 mg administered s.c. once daily for 4 consecutive days from Day 1 chemotherapy | Drug | Placebo |
Primary outcome
Number of Patients experiencing Diarrhea
Time frame: Day 1 to Day 14
Severity of Diarrhea will be classified according to the NCI-CTCAE.
2 secondary outcomes
Safety and tolerability of the administered repeated doses of elsiglutide (ZP1846) will be evaluated
Time frame: Day 1 to Day 32
PK of elsiglutide will be evaluated
Time frame: Day 1 to Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
Related trials for Diarrhea
Not yet recruiting
Comparison of Two Probiotics for Reducing Diarrhea Frequency in Children Aged 6-24 Months
Acute Watery Diarrhea, Acute Watery Diarrhoea
RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Recruiting
Lactic Acid Bacteria in Functional Diarrheal Disorders
IBS-D (Diarrhea-predominant), IBS (Irritable Bowel Syndrome)
RecruitingPhase 2
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
Immune-related Adverse Event, Diarrhea
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.
21 sites in 4 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 Diarrhea, run by Helsinn Healthcare SA at 21 sites in 4 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 30 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 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Russia, Bulgaria, Romania, Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Patients experiencing Diarrhea (time frame: Day 1 to Day 14). 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 26 Mar 2014.