Trials / Completed

CompletedNCT01459653

Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor

International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Chemotherapy-treated Cancer Patients at Risk for Febrile Neutropenia and Treated Prophylactically With Filgrastim Biosimilar.

Status: Completed
Phase: —
Study type: Observational
Enrollment: 1,496 (actual)

Sponsor: Sandoz · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for primary or secondary FN prophylaxis to better describe the patient population at risk for FN and treated prophylactically in physician's best clinical judgement with filgrastim biosimilar (EP2006), to describe prophylaxis patterns involving filgrastim biosimilar (EP2006), and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and experience break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which prophylaxis of FN is in congruence with guideline recommendations.

Conditions

Timeline

Start date: 2010-03-01
Primary completion: 2013-08-01
Completion: 2013-08-01
First posted: 2011-10-25
Last updated: 2016-01-11
Results posted: 2015-07-07

Locations

116 sites across 12 countries: Austria, Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Romania, Spain, Switzerland, United Kingdom

Source: ClinicalTrials.gov record NCT01459653. Inclusion in this directory is not an endorsement.