Symptoms and General Pathology

All Conditions

Diarrhea

Signs and Symptoms, Digestive

Antineoplastic Agents

All Drugs and Chemicals

Fluorouracil

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

Elsiglutide

Placebo

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.

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)

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Proof-of-Concept Study in Cancer Patients to Assess Efficacy of Elsiglutide in Preventing Chemotherapy-Induced Diarrhea	NCT01543451	Diarrhea	Elsiglutide Placebo	18 Years -	Helsinn Healthcare SA
Proof-of-Concept Study in Cancer Patients to Assess Efficacy of Elsiglutide in Preventing Chemotherapy-Induced Diarrhea	NCT01543451	Diarrhea	Elsiglutide Placebo	18 Years -	Helsinn Healthcare SA

Spots Global Cancer Trial Database for elsiglutide

Every month we try and update this database with for elsiglutide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for elsiglutide

Every month we try and update this database with for elsiglutide cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for elsiglutide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.