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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01519700
First received: January 13, 2012
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Chemotherapy Associated Neutropenia
Breast Cancer
Drug: EP2006
Drug: Filgrastim
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Mean duration of Grade 4 neutropenia during Cycle 1 of Chemotherapy [ Time Frame: 21 days (Cycle 1 of chemotheray treatment) ] [ Designated as safety issue: Yes ]
    Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia.


Secondary Outcome Measures:
  • Incidence of febrile neutropenia [ Time Frame: 21 weeks ] [ Designated as safety issue: Yes ]
    Outcome Measure Description: to assess the safety of EP2006 and Filgrastim

  • Incidence, occurrence and severity of (serious) adverse events Assessment of local tolerability Systematic tolerance [ Time Frame: 21 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 218
Study Start Date: December 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EP2006
Eligible patients will be teated with EP2006
Drug: EP2006
Eligible patients will be teated with EP2006
Other Name: Filgrastim
Active Comparator: Filgrastim
Eligible patients will be teated with Filgrastim
Drug: Filgrastim
Eligible patients will be teated with Filgrastim
Other Name: Filgrastim

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519700

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

No publications provided

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01519700     History of Changes
Other Study ID Numbers: EP06-302, 2010-024481-22
Study First Received: January 13, 2012
Last Updated: November 3, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation
Hungary: Ministry of Health, Social and Family Affairs
Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control

Keywords provided by Sandoz:
Filgrastim
G-CSF, neutropenia
supportive care
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neutropenia
Agranulocytosis
Breast Diseases
Hematologic Diseases
Leukocyte Disorders
Leukopenia
Neoplasms
Neoplasms by Site
Skin Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014