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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
218

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sandoz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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