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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Diarrhea

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Trial Information

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)


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.

Inclusion criteria 1-8 will be verified at screening.

Inclusion criteria 8 will be re-confirmed on Day 1.

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).

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Number of Patients experiencing Diarrhea

Outcome Description:

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

Outcome Time Frame:

Day 1 to Day 14

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

TIDE-11-10

NCT ID:

NCT01543451

Start Date:

February 2012

Completion Date:

December 2012

Related Keywords:

  • Diarrhea
  • Diarrhea

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