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

This study is currently recruiting participants.
Verified March 2013 by Sandoz
Sponsor:
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01519700
First received: January 13, 2012
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 192
Study Start Date: December 2011
Estimated Study Completion Date: June 2013
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519700

Contacts
Contact: Sandoz Biopharmaceuticals +49 8024 476 0

Locations
Czech Republic
Insitut Onkologie a Rehabilitaca na Plesi Recruiting
Ves pod Plesi 110, Czech Republic, 26204
Contact: Jan Vydra, MD            
Hungary
Josa Andras Oktato Korhaz Nonprofit Kft Recruiting
Nyiregyhaza, Hungary, 4400
Contact: Jozsef Erfan, Dr            
Latvia
Daugavpils Regional Hospital Recruiting
Daugavpils, Latvia, 5400
Contact: Marianna Bitina, MD            
Russian Federation
State Medical-Prophylactic Institution SMPI Reginal Clinical Oncological Dispensary Recruiting
Chelyabinsk, Russian Federation
Contact: Oleg Gladkov, Prof.            
State Healthcare Institution SHI Regional Oncological Dispensary Recruiting
Magnitogorsk, Russian Federation
Contact: Nina Chekha, Dr.            
State Healthcare Institution SHI Pyatigorsk Oncological Dispensary Recruiting
Pyatigorsk, Russian Federation
Contact: Vladimir Vladimirov, Prof.            
Non-State Healthcare Institution NSHI Recruiting
Saint-Petersburg, Russian Federation
Contact: Vladimir Semiglazov, Prof.            
Serbia
Clinical hospital Centre Bezanijska Kosa Withdrawn
Belgrade, Serbia, 11080
Slovakia
Oddelenie klinickej onkologie, Vyvhodoslovensky onkologicky ustav Recruiting
Kosice, Slovakia, 041 91
Contact: Tibor Packan, MD PhD            
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: March 14, 2013
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
 Leukocyte Disorders
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013