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Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim

NCT01519700 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2015-05-06

Study results available
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Summary

The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

Conditions

Interventions

DRUG

EP2006

Eligible patients will be teated with EP2006

DRUG

Filgrastim

Eligible patients will be teated with Filgrastim

Sponsors & Collaborators

Principal Investigators

  • Sandoz · Sandoz

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Czechia
  • Hungary
  • Latvia
  • Russia
  • Slovakia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01519700 on ClinicalTrials.gov