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
  Purpose

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.


Condition Intervention Phase
Chemotherapy-induced Neutropenia
Biological: empegfilrastim 6 mg
Biological: filgrastim
Biological: Placebo №1
Biological: Placebo №2
Biological: empegfilrastim 7,5 mg
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Biocad:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 135
Study Start Date: September 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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
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
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.
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
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
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: 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

  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;
  • 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.
  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: NCT02104830

Locations
India
HCG Bangalore Institute of Oncology
Bangalore, India, 560027
M.S.Ramaiah Memorial Hospital
Bangalore, India, 560054
M.S.Ramaiah Memorial Hospital
Bangalore, India
Russian Federation
Arkhangelsk District Clinical Oncology Dispensary
Arkhangelsk, Russian Federation, 163045
Clinical Hospital at Chelyabinsk Railway Station
Chelyabinsk, Russian Federation
State public health institution "Regional Oncology Dispensary №1"
Engels, Russian Federation
State public health institution "Republican Clinical Oncology Dispensary" of the Ministry of Health of the Republic of Tatarstan
Kazan, Russian Federation
Clinical Oncology Dispensary N1
Krasnodar, Russian Federation, 350040
State Health Care Institution "Moscow City Oncology Hospital № 62" Moscow Health Department
Moscow, Russian Federation
Non-governmental healthcare institution "Central Clinical Hospital № 2 Semashko" JSC "Russian Railways"
Moscow, Russian Federation
State public health institution "Nizhny Novgorod Regional Oncology Dispensary"
Nizhny Novgorod, Russian Federation
State budget healthcare institution Omsk region "Clinical Oncology Dispensary"
Omsk, Russian Federation
State Health Care Institution "Orenburg Regional Clinical Oncology Dispensary"
Orenburg, Russian Federation
Perm Region Oncology Dispensary
Perm, Russian Federation, 614066
Pyatigorsk Oncology Center
Pyatigorsk, Russian Federation, 357502
Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "
Saransk, Russian Federation
State Health Care Institution "Oncologic Dispensary № 2" Health Department of Krasnodar Area
Sochi, Russian Federation
N.N.Petrov Oncology Research Center
St.Petersburg, Russian Federation, 197758
Military Medical Academy named after S.M. Kirov
St.Petersburg, Russian Federation
State Budget Institution health care "Tula Regional Oncology Dispensary"
Tula, Russian Federation
State public health institution "Regional Clinical Oncology Dispensary"
Ulyanovsk, Russian Federation
Volgograd Regional Oncology Dispensary №3
Volgograd, Russian Federation, 404130
State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1"
Volgograd, Russian Federation
State public health institution "Voronezh Regional Clinical Oncology Dispensary"
Voronezh, Russian Federation
Ukraine
Donetsk City Oncology Dispensary
Donetsk, Ukraine
Donetsk Regional Antitumor Center
Donetsk, Ukraine
Kharkiv Regional Clinical Oncology Center
Kharkiv, Ukraine
Zakarpatskyi Regional Clinical Oncology Center
Uzhhorod, Ukraine
Vinnytsia Regional Clinical Oncology Dispensary
Vinnytsia, Ukraine
Sponsors and Collaborators
Biocad
Investigators
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
  More Information

No publications provided

Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT02104830     History of Changes
Other Study ID Numbers: BCD-017-3
Study First Received: April 2, 2014
Last Updated: April 3, 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
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014