Dose-finding Study of Empegfilgrastim for Neutropenia Pro... | NCT01569087

NCT01569087

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Empegfilgrastim 3 mg	Experimental	Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy	Biological: empegfilrastim
Empegfilgrastim 6 mg	Experimental	Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy	Biological: empegfilrastim
Filgrastim	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
empegfilrastim	Biological	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.

Measure	Description	Time Frame
CTCAE Grade 3/4 Neutropenia Incidence		21 days

Measure	Description	Time Frame
Mean Duration of CTCAE Grade 4 Neutropenia		21 days
The Duration of Any Grade Neutropenia		21 days
Low Level (Nadir) ANC x 10^9/L

Eligibility Module

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.

Name	Affiliation	Role
Roman A. Ivanov, MD, PhD	Biocad	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arkhangelsk District Clinical Oncology Dispensary		Arkhangelsk		163045	Russia
Perm Region Oncology Dispensary

Arm/Group Information

ID	Title	Description
FG000	Empegfilgrastim 3 mg	Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy 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.
FG001	Empegfilgrastim 6 mg	Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy 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.
FG002	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 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Empegfilgrastim 3 mg	Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy 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.
BG001

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

CTCAE Grade 3/4 Neutropenia Incidence

Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)

Posted

Number

participants

21 days

ID	Title	Description
OG000	Empegfilgrastim 3 mg	Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy 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.
OG001	Empegfilgrastim 6 mg	Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy 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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Empegfilgrastim 3 mg	Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy 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.

ID	Term
D009503	Neutropenia
D064147	Febrile Neutropenia
D001943	Breast Neoplasms

ID	Term
D000380	Agranulocytosis
D007970	Leukopenia
D000095542	Cytopenia
D006402	Hematologic Diseases

ID	Term
D016179	Granulocyte Colony-Stimulating Factor
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates