Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biocad
ClinicalTrials.gov Identifier:
NCT02104830
First received: April 2, 2014
Last updated: April 3, 2014
Last verified: April 2014

April 2, 2014
April 3, 2014
September 2013
May 2014   (final data collection date for primary outcome measure)
Duration of neutropenia CTCAE grade 4 [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
The primary endpoint, which will allow to compare the efficacy of the single dose of Extimia® versus nonpegylated daily filgrastim is the number of breast cancer patients developing CTCAE grade 3/4 neutropenia after the first AT chemotherapy cycle (doxorubicin+docetaxel).
Same as current
Complete list of historical versions of study NCT02104830 on ClinicalTrials.gov Archive Site
  • The duration of grade 4 neutropenia from the 2nd to 4th cycles; [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • The incidence of severe neutropenia (grade 3-4) [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Cancer Patients
International Multicenter Randomized Double-blind Phase III Clinical Study Comparing the Efficacy and Safety of a Single Dose Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy

BCD-017-3 is an double-blind randomized phase III 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 6 or 7,5 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients receiving myelosuppressive chemotherapy.

The study also includes the following determination of pharmacokinetic parameters after repeated administration of the study drug.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Chemotherapy-induced Neutropenia
  • Biological: empegfilrastim 6 mg
    Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.
    Other Names:
    • Extimia
    • metpegfilgrastim
    • pegylated filgrastim
    • peg-GCSF
  • 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
  • Biological: Placebo №1
  • Biological: Placebo №2
  • Biological: empegfilrastim 7,5 mg
    Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.
    Other Names:
    • Extimia
    • 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
    Intervention: Biological: Placebo №2
  • Experimental: Empegfilgrastim 7,5 mg
    Patients will receive a single administration of empegfilgrastim at a dose of 7,5 mg subcutaneously, 24 h after the chemotherapy
    Intervention: Biological: Placebo №2
  • Active Comparator: Filgrastim
    Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
    Intervention: Biological: Placebo №1
  • Placebo Comparator: Placebo №1
    Patients will receive a single administration of placebo №1 at a dose of 1 ml subcutaneously, 24 h after the chemotherapy.
    Intervention: Biological: filgrastim
  • Placebo Comparator: Placebo №2
    Patients will receive placebo №2 subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
    Interventions:
    • Biological: empegfilrastim 6 mg
    • Biological: empegfilrastim 7,5 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
135
February 2015
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent form;
  • Histologically verified diagnosis of stage IIb/III/IV breast cancer;
  • Age of 18-70 years inclusive;
  • Life expectancy of at least 6 months after inclusion in the study;
  • 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- 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 250 mg/m2 for doxorubicin or 540 mg/m2 for epirubicin,if in this study planned 6 cycles of chemotherapy ;
  • If the patient had received adjuvant and/or neoadjuvant therapy, the cumulative dose of anthracyclines should not exceed 350 mg/m2 for doxorubicin or 660 mg/m2 for epirubicin,if in this study planned 4 cycles of chemotherapy ;
  • 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;
  • Patients should be able to follow the Protocol procedures (according to Investigator's assessment.

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 3-4 neuropathy;
  • HIV, HCV, HBV, T.Pallidum infection(s);
  • Acute or active chronic infections;
  • Severe concurrent diseases (for example, severe arterial hypertension, severe heart failure, and other);
  • Severe depression, schizophrenia, any other mental disorders;
  • Obstacles in intravenous administration of study drugs;
  • Simultaneous participation in other clinical trials, previous participation in other clinical trials within 30 days before entering into the trial, previous participation in the same trial.
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
India,   Russian Federation,   Ukraine
 
NCT02104830
BCD-017-3
No
Biocad
Biocad
Not Provided
Study Director: Roman Ivanov, MD, PhD Biocad
Principal Investigator: Larisa Bolotina, MD, PhD Federal State Institution "Moscow Research Oncological Institute P.A.Gertsena "of the Ministry of Health of the Russian Federation
Principal Investigator: Olga Brichkova, MD, PhD State public health institution "Regional Oncology Dispensary №1
Principal Investigator: Olga Burdaeva, MD State Budget Institution of Health Arkhangelsk region "Arkhangelsk Clinical Oncology Dispensary"
Principal Investigator: Byakhov Michael, MD, PhD Non-governmental healthcare institution "Central Clinical Hospital № 2 Semashko" JSC "Russian Railways"
Principal Investigator: Vladimir Vladimirov, MD, PhD State Budget Institution of Health Stavropol area "Piatigorsky Oncology Dispensary"
Principal Investigator: Rinat Galiulin, MD State budget healthcare institution Omsk region "Clinical Oncology Dispensary"
Principal Investigator: Oleg Gladkov, MD, PhD State Budget Institution of Health "Chelyabinsk Regional Clinical Oncology Dispensary"
Principal Investigator: Irina Davydenko, PhD State Budget Institution of Health "Clinical Oncology Dispensary № 1" of the Ministry of Health of the Krasnodar area
Principal Investigator: Victoria Elkova, MD State public health institution "Voronezh Regional Clinical Oncology Dispensary"
Principal Investigator: Igor Lifirenko, MD State public health institution "Kursk Regional Oncology Dispensary"
Principal Investigator: Nadezhda Kovalenko, PhD State Budget Institution of Health "Volgograd regional oncologic dispensary № 3"
Principal Investigator: Michael Kopp, MD, PhD State Budget Institution of Health "Samara Regional Clinical Oncology Dispensary"
Principal Investigator: Bogdan Kotiv, MD, PhD Military Medical Academy named after S.M. Kirov
Principal Investigator: Natalia Levchenko, PhD State Budget Institution of Health Stavropol area "Stavropol Regional Clinical Oncology Dispensary"
Principal Investigator: Marina Matrosova, MD State public health institution "Nizhny Novgorod Regional Oncology Dispensary"
Principal Investigator: Guzel Mukhametshina, MD State public health institution "Republican Clinical Oncology Dispensary" of the Ministry of Health of the Republic of Tatarstan
Principal Investigator: Sergei Panchenko, PhD State public health institution "Regional Clinical Oncology Dispensary"
Principal Investigator: Alexander Pecheny, PhD Regional State Health Care Institution "Orlovsky Oncology Dispensary"
Principal Investigator: Igor Pimenov, PhD State Budget Institution health care "Tula Regional Oncology Dispensary"
Principal Investigator: Andrei Sinykov, PhD State Health Care Institution of Tyumen Region "Regional Oncological Dispensary"
Principal Investigator: Pavel Skopin, PhD Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "
Principal Investigator: Daniil Stroyakovsky State Health Care Institution "Moscow City Oncology Hospital № 62" Moscow Health Department
Principal Investigator: Sergei Tyulyandin, MD, PhD "Russian Oncological Scientific Center N.N.Blokhin" Russian Academy of Sciences
Principal Investigator: Dmitriy Udovica, MD State Health Care Institution "Oncologic Dispensary № 2" Health Department of Krasnodar Area
Principal Investigator: Andrei Horinko, MD State Health Care Institution "Perm Regional Oncology Dispensary"
Principal Investigator: Petr Krivorotko, MD N.N. Petrov Oncology Research Center of the Ministry of Health of the Russian Federation
Principal Investigator: Yulia Shapovalova, PhD Non-governmental healthcare institution "Chelyabinsk Road Clinical Hospital" JSC "Russian Railways"
Principal Investigator: Ludmila Sheveleva, MD State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1"
Principal Investigator: Vadim Shirinkin, MD State Health Care Institution "Orenburg Regional Clinical Oncology Dispensary"
Principal Investigator: Shekar Patil, MD Bangalore Institute of Oncology
Principal Investigator: Prasad Narayanan, MD Mazumdar Shaw Cancer Center and Narayana Hrudayalaya Multispecialty Hosptial
Principal Investigator: Nalini Kilara, MD M.S.Ramaiah Memorial Hospital
Principal Investigator: Sergei Kulik, MD Donetsk City Municipal Oncology Dispensary
Principal Investigator: Igor Sedakov, MD, PhD Donetsk Regional oncology centers
Principal Investigator: Andrei Rusin, MD,PhD Zakarpatskii Regional Clinical Oncology Dispensary
Principal Investigator: Yuri Vinnik, MD, PhD Kharkiv Regional Clinical Oncology Center
Principal Investigator: Sergei Odarchenko, PhD Vinnitskii Regional Oncology Dispensary
Biocad
April 2014

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