Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biocad
ClinicalTrials.gov Identifier:
NCT01569087
First received: March 30, 2012
Last updated: January 10, 2014
Last verified: December 2013
  Purpose

BCD-017-2 is an open-label randomized phase II clinical study to compare the incidence of CTCAE grade 3/4 neutropenia after a single administration of recombinant human pegylated filgrastim empegfilgrastim (Extimia®) at a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients receiving myelosuppressive chemotherapy.


Condition Intervention Phase
Chemotherapy-induced Neutropenia
Biological: empegfilrastim
Biological: filgrastim
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomized Multicenter Open-label Phase II Clinical Study Comparing the Efficacy and Safety of the Single Dose of Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy

Resource links provided by NLM:


Further study details as provided by Biocad:

Primary Outcome Measures:
  • CTCAE grade 3/4 neutropenia incidence [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median duration of CTCAE grade 4 neutropenia [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: May 2012
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Empegfilgrastim 3 mg
Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
Biological: empegfilrastim
Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
Other Names:
  • Extimia
  • BCD-017
  • metpegfilgrastim
  • pegylated filgrastim
  • peg-GCSF
Experimental: Empegfilgrastim 6 mg
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
Biological: empegfilrastim
Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
Other Names:
  • Extimia
  • BCD-017
  • metpegfilgrastim
  • pegylated filgrastim
  • peg-GCSF
Active Comparator: Filgrastim
Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
Biological: filgrastim
Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
Other Name: GCSF

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent form;
  • Histologically verified diagnosis of stage IIb/III/IV breast cancer;
  • Age of 18-70 years inclusive;
  • If the patient had received the chemotherapy for breast cancer, it should be finished 30 days before the beginning of the study;
  • ECOG Performance Status of 0, 1 or 2, not increasing within during 2 weeks before randomization;
  • ANC level of 1500/μL and more at the beginning of the study
  • Platelet count of 100 000/μL and more at the beginning of the study
  • Hemoglobin level of 90 g/l and more
  • Creatinine level <1.5 mg/dl
  • Total bilirubin level <1.5 × the upper limit of normal (ULN)
  • ALT and/or AST levels <2.5×ULN (5×ULN for patients with liver metastases);
  • Alkaline phosphatase <5×ULN;
  • Left ventricular ejection fraction >50% and more;
  • If the patient had received adjuvant and/or neoadjuvant therapy, the cumulative dose of anthracyclines should not exceed 500 mg/m2 for doxorubicin or 500 mg/m2 for epirubicin;
  • Ability of the participant to follow the protocol requirements, according to the Investigator's opinion;
  • Patients of childbearing potential must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior randomization and for 6 months after the last administration of the study drug.

Exclusion Criteria:

  • Patient has received two or more chemotherapy regimens for the metastatic breast cancer;
  • Documented hypersensitivity to filgrastim, pegfilgrastim, docetaxel, doxorubicin, dexamethasone and/or its excipients, PEGylated drugs, recombinant proteins.
  • Pregnancy or breastfeeding;
  • Systemic antibiotic therapy within 72 h prior empegfilgrastim/filgrastim administration;
  • Concomitant radiotherapy (except selective radiotherapy of bone metastases);
  • Surgery, radiotherapy (except selective radiotherapy of bone metastases), administration of any experimental drugs within 30 days prior randomization;
  • History of bone marrow/stem cell transplantation;
  • Conditions limiting the patient's ability to follow the protocol;
  • CTCAE grade 2/4 neuropathy
  • HIV, HCV, HBV, T.Pallidum infection(s);
  • Acute or active chronic infections.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569087

Locations
Russian Federation
Arkhangelsk District Clinical Oncology Dispensary
Arkhangelsk, Russian Federation, 163045
Perm Region Oncology Dispensary
Perm, Russian Federation, 614066
Russian scientific center of radiology and surgery technologies
St.Petersburg, Russian Federation
N.N.Petrov Oncology Research Center
St.Petersburg, Russian Federation, 197758
Volgograd District Oncology Dispensary №1
Volgograd, Russian Federation, 400138
Sponsors and Collaborators
Biocad
Investigators
Study Director: Roman A. Ivanov, MD, PhD Biocad
  More Information

No publications provided

Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT01569087     History of Changes
Other Study ID Numbers: BCD-017-2
Study First Received: March 30, 2012
Last Updated: January 10, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Biocad:
empegfilgrastim
pegylated filgrastim
neutropenia
febrile neutropenia
chemotherapy-associated neutropenia
breast cancer
docetaxel
doxorubicin

Additional relevant MeSH terms:
Neutropenia
Breast Neoplasms
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 April 15, 2014