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Trial record 1 of 1 for:    NCT01079676
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A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01079676
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : October 16, 2012
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.

Tracking Information
First Submitted Date  ICMJE March 2, 2010
First Posted Date  ICMJE March 3, 2010
Last Update Posted Date October 16, 2012
Study Start Date  ICMJE March 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
The study primary endpoint will be the rate of grade 4 neutropenia after the first cycle of chemotherapy, according to the classification Common Terminology Criteria for Adverse Events (CTC-AE) [ Time Frame: 5 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
The febrile neutropenia rate. [ Time Frame: 5 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer
Official Title  ICMJE A Phase III, Non-inferiority Study Comparing Two Filgrastim Preparations in Preventing Chemotherapy Induced Neutropenia in Breast Cancer
Brief Summary This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.
Detailed Description

This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product. For this, the study primary endpoint will be the rate of grade 4 neutropenia after the first cycle of chemotherapy, according to the classification Common Terminology Criteria for Adverse Events (CTC-AE).

The study secondary objectives will be to compare other efficacy aspects, as well as the tolerability of the two products containing filgrastim.

The secondary endpoints considered for the study will be:

  • The febrile neutropenia rate;
  • The rate of any grade 4 neutropenia;
  • The duration of the grade 4 neutropenia;
  • The frequency of the adverse events and the laboratory changes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Neutropenia in Breast Cancer
Intervention  ICMJE
  • Drug: Filgrastim (Eurofarma)
    Filgrastim will be given at the daily dose of 5 µg/kg body weight, subcutaneously. The weight considered will be the actual weight, for patients weighing up to 120 kg.
  • Drug: Filgrastim (Granulokine, Amgen)
    Granulokine will be given at the daily dose of 5 µg/kg body weight, subcutaneously. The weight considered will be the actual weight, for patients weighing up to 120 kg.
Study Arms  ICMJE
  • Experimental: Filgrastim
    Intervention: Drug: Filgrastim (Eurofarma)
  • Active Comparator: Granulokine
    Intervention: Drug: Filgrastim (Granulokine, Amgen)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2010)
220
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed ICF;
  • Diagnosis confirmed by anatomic pathology examination (cytology or histopathology) of breast cancer;
  • Clinical or imaging confirmation of stage II to IV disease, according to the TNM classification;
  • Indication for chemotherapy with one of the eligible regimens, as long as the treatment in the first cycle is planned as full dose (without adjustments relative to the original regimen);
  • Performance status from 0 to 1 on the Zubrod scale;
  • No more than one previous chemotherapeutic regimen for metastatic disease;
  • Proper organic functions, as indicated by all the following conditions:

    • ANC >1500/mm3;
    • Platelet count >150000/mm3;
    • Serum creatinine <1,2 mg/dL;
    • Bilirubins and transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) <1.5 times the upper limit of normal.

Exclusion Criteria:

  • Forecast of prophylactic or therapeutic use of antibiotics, antifungal or antiviral in the first cycle of chemotherapy;
  • Previous radiotherapy involving pelvis or radiotherapy of any site on the last 6 weeks before randomization;
  • History of bone marrow transplantation (as receptor);
  • Presence of other neoplasias, with the exception of in situ cervical carcinoma, in situ bladder carcinoma, cutaneous basal cell carcinoma properly treated, cutaneous spinocellular carcinoma properly treated, T1 vocal cords cancer under remission or previous malignant neoplasia treated more than 5 years before the recruitment and without relapse;
  • Presence of severe comorbidities, such as cardiovascular, chronic respiratory, kidney, liver, neurological, hematological, infectious, skin, neurological or psychiatric disease;
  • Recent (< 12 months) or foreseen participation during this study in other clinical studies involving any nature of drugs or studies of any kind of intervention, unless there may be a direct benefit to the research subject, as per CNS/MS Resolution 251/97, item III.j.
  • Intolerability or allergy to any of the components of the filgrastim formulations evaluated in the study.
  • Pregnancy or lactation (patients of childbearing potential must have a negative blood pregnancy test on the 7 days prior to the randomization).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01079676
Other Study ID Numbers  ICMJE EF-026
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eurofarma Laboratorios S.A.
Study Sponsor  ICMJE Eurofarma Laboratorios S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eurofarma Laboratorios S.A.
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP