Spots Global Cancer Trial Database for Proof-of-Concept Study in Cancer Patients to Assess Efficacy of Elsiglutide in Preventing Chemotherapy-Induced Diarrhea
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Trial Identification
Brief Title: Proof-of-Concept Study in Cancer Patients to Assess Efficacy of Elsiglutide in Preventing Chemotherapy-Induced Diarrhea
Official Title: 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)
Study ID: NCT01543451
Conditions
Study Description
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of Chemotherapy, Complex Oncology Center, Ruse, , Bulgaria
Chemotherapy Department, Complex Oncology Center, Shumen, , Bulgaria
Department of Chemotherapy Specialized Hospital for Active Treatment of Oncological Diseases, Sofia, , Bulgaria
Department of Chemotherapy Specialized Hospital for Active Treatment of Oncological Diseases, Sofia, , Bulgaria
Oncology Clinic, Multiprofile Hospital for Active Treatment "Sveta Marina", Varna, , Bulgaria
Semmelweis University, Department of Diagnostic Radiology and Oncotherapy, Budapest, , Hungary
Kenezy Hospital, Department of Clinical Pharmacology, Infectology and Allergology, Debrecen, , Hungary
Petz Aladar County Teaching Hospital, Center of Oncologic Radiology Hungary, Gyor, , Hungary
Szeged Medical University Department of Oncology and Oncotherapy, Szeged, , Hungary
Prof. Dr. Ion Chiricuta Institute of Oncology, Medical Oncology Department, Cluj-Napoca, Cluj County, Romania
Euroclinic Oncology Center SRL - Medical Oncology Department, Iasi, Iasi county, Romania
Dr. Constantin Opris Clinical Country Emergency Hospital Baia Mare, Department of Oncology, Baia Mare, Maramures County, Romania
Sf. Ioan cel Nou Emergency Clincal County Hospital, Suceava, Suceava county, Romania
Fundeni Clinical Institute - Medical Oncology Department, Bucharest, , Romania
City #9 Hospital, Saint-Petersburg, St. Petersburg, Russian Federation
City Clinical Oncology Center, Saint-Petersburg, St. Petersburg, Russian Federation
Regional Clinical Oncology Center - Chemotherapy Department, Ulyanovsk, Ulyanovsk region, Russian Federation
Regional Oncology Center, Arkhangelsk, , Russian Federation
Kursk Regional Clinical Oncology Center, Kursk, , Russian Federation
Pyatigorsk Oncology Center, Pyatigorsk, , Russian Federation
Regional Oncology Hospital, Yaroslavl, , Russian Federation
Contact Details
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