Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim (PIONEER)

April 14, 2015 updated by: Sandoz

A Randomized, Double-blind, Parallel-group, Multi-center Phase III Study Comparing the Efficacy and Safety of EP2006 and Neupogen® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Ves pod Plesi 110, Czech Republic, 26204
        • Insitut Onkologie a Rehabilitaca na Plesi
  • Hungary
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem, III. Belgyogyaszati Klinika
      • Budapest, Hungary, 1145
        • Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia
      • Debrecen, Hungary, 4032
        • DE OEC, Onkologiai Tanszek
      • Nyiregyhaza, Hungary, 4400
        • Josa Andras Oktato Korhaz Nonprofit Kft
      • Szekesfehervar, Hungary, 8000
        • Fejer Megyei Szent Gyorgy Korhaz, Onkologiai Osztaly
      • Szombathely, Hungary, 9700
        • Vas Megyei Markusovszky Korhaz, Onkoradiologiai Osztaly
  • Latvia
      • Daugavpils, Latvia, 5400
        • Daugavpils Regional Hospital
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • State Medical-Prophylactic Institution SMPI Reginal Clinical Oncological Dispensary
      • Krasnodar, Russian Federation, 350040
        • State Healthcare Institution (SHI) "Clinical Oncological Dispensary №1" of Healthcare Department of Krasnodar Territory
      • Moscow, Russian Federation, 115478
        • Institution of the Russian Academy of Medical Sciences Russian Oncology Research Center n.a. N.N.Blochin of RAMS", Surgery Department of the Female Reproductive System Tumors
      • Nizhny Novgorod, Russian Federation, 603081
        • Affiliate No1 of State Healthcare Institution (SHI) "Nizhny Novgorod Regional Oncological Dispensary"
      • Obninsk, Russian Federation, 249036
        • Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS
      • Pyatigorsk, Russian Federation, 357502
        • State Healthcare Institution SHI Pyatigorsk Oncological Dispensary
      • Saint-Petersburg, Russian Federation, 195271
        • Non-State Healthcare Institution NSHI
      • Saint-Petersburg, Russian Federation, 197022
        • Saint-Petersburg State Healthcare Institution (SPb SHI) "City Clinical Oncological Dispensary"
      • Voronezh, Russian Federation, 394000
        • State Healthcare Institution (SHI)"Voronezh Regional Clinical Oncological Dispensary"
    • Krasnogorsk district
      • Moscow, Krasnogorsk district, Russian Federation, 143423
        • Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS
    • Leningrad region
      • Kuzmolovsky, Leningrad region, Russian Federation, 188663
        • State Healthcare Institution (SHI) "Leningrad Regional Oncological Dispensary" at the Surgery Department 2
  • Slovakia
      • Nitra, Slovakia, 95001
        • Fakultna nemocnica Nitra, Oddelenie radioterapie a klinickej onkologie
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • Communal Institution "Dnipropetrovsk Сity multiple-discipline Clinical Hospital 4" of Dnipropetrovsk Regional Council
      • Lugansk, Ukraine, 91000
        • Medical center of Limited Liability Company "Inter"
      • Lviv, Ukraine, 79031
        • Lviv state oncological regional treatment-and-diagnostics center, Chemotherapy Department
      • Odesa, Ukraine, 65025
        • Communal Institution "Odesa regional clinical hospital", Mammology Center
      • Vinnitsya, Ukraine, 21029
        • Vinnytsya Regional Clinical Oncological Center, Chemotherapy Department
    • Dnipropetrovsk region
      • Kriviy Rig, Dnipropetrovsk region, Ukraine, 50048
        • Communal Institution "Krivorizhskiy oncology dispensary" of Dnipropetrovsk regional Council, Chemotherapy Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy
  2. Women ≥ 18 years of age
  3. Estimated life expectancy of more than six months

Exclusion Criteria:

  1. Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry
  2. Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.:

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EP2006
Eligible patients will be teated with EP2006
Drug: EP2006
Eligible patients will be teated with EP2006
Other Names:
  • Filgrastim
ACTIVE_COMPARATOR: Filgrastim
Eligible patients will be teated with Filgrastim
Drug: Filgrastim
Eligible patients will be teated with Filgrastim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy
Time Frame: 21 days (Cycle 1 of chemotherapy treatment)
Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5*10^9 cells/L)
21 days (Cycle 1 of chemotherapy treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Febrile Neutropenia
Time Frame: 21 weeks/ 6 cycles
Incidence of febrile neutropenia by duraton within each cycle and across all cycles. Febrile neutropenia is defined as oral temperature greater than or equal 38.3°C while having an Absolute Neutrophil Count < 0.5*10^9 cells/L (both measured on the same day)
21 weeks/ 6 cycles
Number of Days of Fever
Time Frame: 21 weeks/ 6 cycles
Number of days of fever by cycle. Fever is defined as oral temperature greater than or equal to 38.3°C.
21 weeks/ 6 cycles
Depth of Absolute Neutrophil Count Nadir
Time Frame: Cycle 1/ 21 days
Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1
Cycle 1/ 21 days
Time to Absolute Neutrophil Count Recovery
Time Frame: Cycle 1/ 21 days
Time to Absolute Neutrophil Count recovery, defined as the time in days from Absolute Neutrophil Count nadir until the patient's Absolute Neutrophil Count increases to more or equal to 2*10^9 cells/L after the nadir in cycle 1
Cycle 1/ 21 days
Frequency of Infections
Time Frame: 21 Weeks/ 6 cycles
Frequency of infections by cycle and across all cycles
21 Weeks/ 6 cycles
Incidence of Hospitalizations Due to Febrile Neutropenia
Time Frame: 21 Weeks/ 6 cycles
Incidence of hospitalizations due to Febrile Neutropenia
21 Weeks/ 6 cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Investigators

  • Study Chair: Sandoz, Sandoz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

January 13, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (ESTIMATE)

January 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP06-302
  • 2010-024481-22 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on EP2006

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe