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

Primary Purpose

Chemotherapy-induced Neutropenia

Status

Completed

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

empegfilrastim

filgrastim

About this trial

This is an interventional supportive care trial for Chemotherapy-induced Neutropenia focused on measuring empegfilgrastim, pegylated filgrastim, neutropenia, febrile neutropenia, chemotherapy-associated neutropenia, breast cancer, docetaxel, doxorubicin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arkhangelsk District Clinical Oncology Dispensary
Perm Region Oncology Dispensary
N.N.Petrov Oncology Research Center
Russian scientific center of radiology and surgery technologies
Volgograd District Oncology Dispensary №1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Empegfilgrastim 3 mg

Empegfilgrastim 6 mg

Filgrastim

Arm Description

Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy

Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy

Outcomes

Primary Outcome Measures

CTCAE Grade 3/4 Neutropenia Incidence

Secondary Outcome Measures

Mean Duration of CTCAE Grade 4 Neutropenia

The Duration of Any Grade Neutropenia

Low Level (Nadir) ANC x 10^9/L

Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy

Incidence of Febrile Neutropenia

Full Information

NCT ID

NCT01569087

First Posted

March 30, 2012

Last Updated

October 24, 2016

Sponsor

Biocad

1. Study Identification

Unique Protocol Identification Number

NCT01569087

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biocad

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy-induced Neutropenia

Keywords

empegfilgrastim, pegylated filgrastim, neutropenia, febrile neutropenia, chemotherapy-associated neutropenia, breast cancer, docetaxel, doxorubicin

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Empegfilgrastim 3 mg

Arm Type

Experimental

Arm Description

Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy

Arm Title

Empegfilgrastim 6 mg

Arm Type

Experimental

Arm Description

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy

Arm Title

Filgrastim

Arm Type

Active Comparator

Arm Description

Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy

Intervention Type

Biological

Intervention Name(s)

empegfilrastim

Other Intervention Name(s)

Extimia, BCD-017, metpegfilgrastim, pegylated filgrastim, peg-GCSF, empegfilgrastim

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

filgrastim

Other Intervention Name(s)

GCSF

Intervention Description

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.

Primary Outcome Measure Information:

Title

CTCAE Grade 3/4 Neutropenia Incidence

Time Frame

21 days

Secondary Outcome Measure Information:

Title

Mean Duration of CTCAE Grade 4 Neutropenia

Time Frame

21 days

Title

The Duration of Any Grade Neutropenia

Time Frame

21 days

Title

Low Level (Nadir) ANC x 10^9/L

Time Frame

21 days

Title

Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy

Time Frame

21 days

Title

Incidence of Febrile Neutropenia

Time Frame

21 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roman A. Ivanov, MD, PhD

Organizational Affiliation

Biocad

Official's Role

Study Director

Facility Information:

Facility Name

Arkhangelsk District Clinical Oncology Dispensary

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Perm Region Oncology Dispensary

City

Perm

ZIP/Postal Code

614066

Country

Russian Federation

Facility Name

N.N.Petrov Oncology Research Center

City

St.Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Russian scientific center of radiology and surgery technologies

City

St.Petersburg

Country

Russian Federation

Facility Name

Volgograd District Oncology Dispensary №1

City

Volgograd

ZIP/Postal Code

400138

Country

Russian Federation

12. IPD Sharing Statement

Links:

URL

http://www.biocad.ru

Description

Related Info

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

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