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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helsinn Healthcare SA
ClinicalTrials.gov Identifier:
NCT01543451
First received: February 21, 2012
Last updated: February 27, 2014
Last verified: February 2014

February 21, 2012
February 27, 2014
February 2012
January 2013   (final data collection date for primary outcome measure)
Number of Patients experiencing Diarrhea [ Time Frame: Day 1 to Day 14 ] [ Designated as safety issue: No ]
Severity of Diarrhea will be classified according to the NCI-CTCAE.
Same as current
Complete list of historical versions of study NCT01543451 on ClinicalTrials.gov Archive Site
  • Safety and tolerability of the administered repeated doses of elsiglutide (ZP1846) will be evaluated [ Time Frame: Day 1 to Day 32 ] [ Designated as safety issue: Yes ]

    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
  • PK of elsiglutide will be evaluated [ Time Frame: Day 1 to Day 5 ] [ Designated as safety issue: No ]

    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

Same as current
Not Provided
Not Provided
 
Proof-of-Concept Study in Cancer Patients to Assess Efficacy of Elsiglutide in Preventing Chemotherapy-Induced Diarrhea
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Diarrhea
  • Drug: Elsiglutide
    24 mg administered s.c. once daily for 4 consecutive days from Day 1 chemotherapy
  • Drug: Placebo
    24 mg administered s.c. once daily for 4 consecutive days from Day 1 chemotherapy
  • Experimental: Elsiglutide
    Intervention: Drug: Elsiglutide
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
October 2013
January 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Hungary,   Romania,   Russian Federation
 
NCT01543451
TIDE-11-10
Yes
Helsinn Healthcare SA
Helsinn Healthcare SA
Not Provided
Not Provided
Helsinn Healthcare SA
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP