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

NCT ID: NCT01543451

Last Updated: 2014-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Elsiglutide

Group Type: EXPERIMENTAL

Elsiglutide

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Elsiglutide

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Written informed consent;

2. Male or female patient ≥ 18 years of age;

3. Confirmed diagnosis of colorectal cancer;

4. Chemotherapy naïve patient;

5. 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

6. A performance status of ≤ 2 according to the Eastern Cooperative Oncology Group(ECOG);

7. Non-fertile patient or fertile patient (male or female) using reliable contraceptive measures

8. Female patient of childbearing potential; need to have a negative pregnancy test at screening.

Exclusion Criteria

1. Inability to understand study procedures and/or cooperate with the study Investigator;

2. Any investigational drugs within 30 days before enrollment in the study or foreseen use of investigational agents during the study;

3. Patient with any type of ostomy;

4. Any previous radiotherapy to the abdomen or pelvis;

5. Scheduled to receive radiotherapy to abdomen or pelvis during the study (Day 1 to Day 14);

6. 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;

7. Previous use or scheduled to receive monoclonal antibodies (e.g. bevacizumab, cetuximab, etc) during the study (From Day 1 to Day 14);

8. Major surgery within the previous 3 weeks;

9. 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;

10. Any diarrhea in the 48 hours preceding study drug administration;

11. Use of anti-diarrheal agents within the 48 hours prior to study drug administration;

12. Use of laxatives within 7 days prior to study drug administration;

13. Use of antibiotics within 7 days prior to study drug administration;

14. History of chronic (≥ 30 consecutive days) use of laxatives;

15. Active and ongoing systemic infection;

16. Lactating woman;

17. History of hypersensitivity or allergies to drugs or compounds potentially related to this investigational drug class;

18. Previous exposure to GLP-2 or other compounds in this investigational drug class;

19. 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;

20. Concomitant bleeding disorders;

21. Other serious concomitant illness, which could interfere with the study;

22. Patient who participated in a previous study with elsiglutide (ZP1846).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinn Healthcare SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Chemotherapy, Complex Oncology Center

Rousse, Ruse, Bulgaria

Chemotherapy Department, Complex Oncology Center

Shumen, Shumen, Bulgaria

Department of Chemotherapy Specialized Hospital for Active Treatment of Oncological Diseases

Sofia, Sofia, Bulgaria

Department of Chemotherapy Specialized Hospital for Active Treatment of Oncological Diseases

Sofia, Sofia, Bulgaria

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

Varna, Varna, Bulgaria

Semmelweis University, Department of Diagnostic Radiology and Oncotherapy

Budapest, Budapest, Hungary

Kenezy Hospital, Department of Clinical Pharmacology, Infectology and Allergology

Debrecen, Debrecen, Hungary

Petz Aladar County Teaching Hospital, Center of Oncologic Radiology Hungary

Győr, Hungary, Hungary

Szeged Medical University Department of Oncology and Oncotherapy

Szeged, Szeged, Hungary

Fundeni Clinical Institute - Medical Oncology Department

Bucharest, Bucharest, Romania

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

Cluj-Napoca, Cluj, Romania

Euroclinic Oncology Center SRL - Medical Oncology Department

Iași, Iaşi, Romania

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

Baia Mare, Maramureş, Romania

Sf. Ioan cel Nou Emergency Clincal County Hospital

Suceava, Suceava, Romania

Regional Oncology Center

Arkhangelsk, Arkhangelskaya oblast, Russia

Kursk Regional Clinical Oncology Center

Kursk, Kursk Oblast, Russia

Pyatigorsk Oncology Center

Pyatigorsk, Pyatigorsk, Russia

City #9 Hospital

Saint Petersburg, Sankt-Peterburg, Russia

City Clinical Oncology Center

Saint Petersburg, Sankt-Peterburg, Russia

Regional Clinical Oncology Center - Chemotherapy Department

Ulyanovsk, Ulyanovsk Oblast, Russia

Regional Oncology Hospital

Yaroslavl, Yaroslavl Oblast, Russia

Countries

Bulgaria; Hungary; Romania; Russia

Other Identifiers

TIDE-11-10

Identifier Type: -

Identifier Source: org_study_id