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

Chemotherapy-induced Neutropenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569087
• Other study ID #: BCD-017-2
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2012
• Last updated: January 10, 2014
• Start date: May 2012
• Est. completion date: February 2013

Study information

• Verified date: December 2013
• 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-017-2 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• 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;

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chemotherapy-induced Neutropenia
• Neutropenia

Intervention

Biological:
• 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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Arkhangelsk District Clinical Oncology Dispensary	Arkhangelsk
Russian Federation	Perm Region Oncology Dispensary	Perm
Russian Federation	N.N.Petrov Oncology Research Center	St.Petersburg
Russian Federation	Russian scientific center of radiology and surgery technologies	St.Petersburg
Russian Federation	Volgograd District Oncology Dispensary ?1	Volgograd

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CTCAE grade 3/4 neutropenia incidence		21 days	No
Secondary	Median duration of CTCAE grade 4 neutropenia		21 days	No