Proof-of-Concept Study in Cancer Patients to Assess Efficacy of Elsiglutide in Preventing Chemotherapy-Induced Diarrhea

NCT01543451 | Completed Phase 2 DMC

• 1 other identifier: TIDE-11-10
• Study Type: interventional
• Target: 138
• Locations: 4 countries
• Sites: 21

Brief 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.

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (1)

• Number of Patients experiencing Diarrhea

  Severity of Diarrhea will be classified according to the NCI-CTCAE.

  Day 1 to Day 14

Secondary Outcomes (2)

• Safety and tolerability of the administered repeated doses of elsiglutide (ZP1846) will be evaluated

  Day 1 to Day 32

• PK of elsiglutide will be evaluated

  Day 1 to Day 5

Study Arms (2)

Elsiglutide

EXPERIMENTAL

Drug: Elsiglutide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Elsiglutide DRUG

24 mg administered s.c. once daily for 4 consecutive days from Day 1 chemotherapy

Elsiglutide

Placebo DRUG

24 mg administered s.c. once daily for 4 consecutive days from Day 1 chemotherapy

Placebo

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 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
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Helsinn Healthcare SA: lead

Study Sites (21)

Department of Chemotherapy, Complex Oncology Center

Rousse, Ruse, 7002, Bulgaria

Location

Chemotherapy Department, Complex Oncology Center

Shumen, Shumen, 9700, Bulgaria

Location

Department of Chemotherapy Specialized Hospital for Active Treatment of Oncological Diseases

Sofia, Sofia, 1233, Bulgaria

Location

Department of Chemotherapy Specialized Hospital for Active Treatment of Oncological Diseases

Sofia, Sofia, 1784, Bulgaria

Location

Oncology Clinic, Multiprofile Hospital for Active Treatment "Sveta Marina"

Varna, Varna, 9010, Bulgaria

Location

Semmelweis University, Department of Diagnostic Radiology and Oncotherapy

Budapest, Budapest, H-1082, Hungary

Location

Kenezy Hospital, Department of Clinical Pharmacology, Infectology and Allergology

Debrecen, Debrecen, H-4043, Hungary

Location

Petz Aladar County Teaching Hospital, Center of Oncologic Radiology Hungary

Győr, Hungary, 9024, Hungary

Location

Szeged Medical University Department of Oncology and Oncotherapy

Szeged, Szeged, H-6720, Hungary

Location

Fundeni Clinical Institute - Medical Oncology Department

Bucharest, Bucharest, 022328, Romania

Location

Prof. Dr. Ion Chiricuta Institute of Oncology, Medical Oncology Department

Cluj-Napoca, Cluj, 400015, Romania

Location

Euroclinic Oncology Center SRL - Medical Oncology Department

Iași, Iaşi, 700106, Romania

Location

Dr. Constantin Opris Clinical Country Emergency Hospital Baia Mare, Department of Oncology

Baia Mare, Maramureş, 430031, Romania

Location

Sf. Ioan cel Nou Emergency Clincal County Hospital

Suceava, Suceava, 720237, Romania

Location

Regional Oncology Center

Arkhangelsk, Arkhangelskaya oblast, 163045, Russia

Location

Kursk Regional Clinical Oncology Center

Kursk, Kursk Oblast, 305035, Russia

Location

Pyatigorsk Oncology Center

Pyatigorsk, Pyatigorsk, 357502, Russia

Location

City #9 Hospital

Saint Petersburg, Sankt-Peterburg, 197110, Russia

Location

City Clinical Oncology Center

Saint Petersburg, Sankt-Peterburg, 198255, Russia

Location

Regional Clinical Oncology Center - Chemotherapy Department

Ulyanovsk, Ulyanovsk Oblast, 432063, Russia

Location

Regional Oncology Hospital

Yaroslavl, Yaroslavl Oblast, 150054, Russia

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 21, 2012
• First Posted: March 5, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 26, 2014

Record last verified: 2014-02

Locations

RO (5); BU (5); HU (4); RU (7)