NCT01569087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

October 24, 2016

Completed
Last Updated

December 5, 2016

Status Verified

October 1, 2016

Enrollment Period

8 months

First QC Date

March 30, 2012

Results QC Date

February 5, 2015

Last Update Submit

October 24, 2016

Conditions

Chemotherapy-induced Neutropenia

Keywords

empegfilgrastimpegylated filgrastimneutropeniafebrile neutropeniachemotherapy-associated neutropeniabreast cancerdocetaxeldoxorubicin

Outcome Measures

Primary Outcomes (1)

  • CTCAE Grade 3/4 Neutropenia Incidence

    21 days

Secondary Outcomes (5)

  • 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

    21 days

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

    21 days

  • Incidence of Febrile Neutropenia

    21 days

Study Arms (3)

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

empegfilrastimBIOLOGICAL

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.

Also known as: Extimia, BCD-017, metpegfilgrastim, pegylated filgrastim, peg-GCSF, empegfilgrastim
Empegfilgrastim 3 mgEmpegfilgrastim 6 mg
filgrastimBIOLOGICAL

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.

Also known as: GCSF
Filgrastim

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Arkhangelsk District Clinical Oncology Dispensary

Arkhangelsk, 163045, Russia

Location

Perm Region Oncology Dispensary

Perm, 614066, Russia

Location

N.N.Petrov Oncology Research Center

Saint Petersburg, 197758, Russia

Location

Russian scientific center of radiology and surgery technologies

Saint Petersburg, Russia

Location

Volgograd District Oncology Dispensary №1

Volgograd, 400138, Russia

Location

MeSH Terms

Conditions

NeutropeniaFebrile NeutropeniaBreast Neoplasms

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Roman Ivanov, Director of Clinical Trials
Organization
Biocad
ivanov@biocad.ru
+7 (812) 380 49 33

Study Officials

  • Roman A. Ivanov, MD, PhD

    Biocad

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2012

First Posted

April 2, 2012

Study Start

May 1, 2012

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

December 5, 2016

Results First Posted

October 24, 2016

Record last verified: 2016-10

Locations

RU(5)