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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02104830
Other study ID # BCD-017-3
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received April 2, 2014
Last updated April 3, 2014
Start date September 2013
Est. completion date February 2015

Study information

Verified date April 2014
Source Biocad
Contact n/a
Is FDA regulated No
Health authority Russia: Ministry of Health of the Russian Federation
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 135
Est. completion date February 2015
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

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.
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.
Placebo ?1

Placebo ?2

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.

Locations

Country Name City State
India HCG Bangalore Institute of Oncology Bangalore
India M.S.Ramaiah Memorial Hospital Bangalore
India M.S.Ramaiah Memorial Hospital Bangalore
Russian Federation Arkhangelsk District Clinical Oncology Dispensary Arkhangelsk
Russian Federation 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 Non-governmental healthcare institution "Central Clinical Hospital ? 2 Semashko" JSC "Russian Railways" Moscow
Russian Federation State Health Care Institution "Moscow City Oncology Hospital ? 62" Moscow Health Department 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 Pyatigorsk Oncology Center Pyatigorsk
Russian Federation 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 Military Medical Academy named after S.M. Kirov St.Petersburg
Russian Federation N.N.Petrov Oncology Research Center 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 State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary ? 1" Volgograd
Russian Federation Volgograd Regional Oncology Dispensary ?3 Volgograd
Russian Federation State public health institution "Voronezh Regional Clinical Oncology Dispensary" Voronezh
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

Sponsors (1)

Lead Sponsor Collaborator
Biocad

Countries where clinical trial is conducted

India,  Russian Federation,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of neutropenia CTCAE grade 4 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). 3 weeks Yes
Secondary The duration of grade 4 neutropenia from the 2nd to 4th cycles; 12 weeks Yes
Secondary The incidence of severe neutropenia (grade 3-4) 16 weeks Yes
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