NCT02521441

Brief Summary

This was a randomized, open-label, active-controlled, dose-finding, phase II study to evaluate the efficacy and safety of 2 doses of F-627 compared to Filgrastim in women with breast cancer receiving myelotoxic chemotherapy. Subjects would be randomized to one of three arms, which were 10 mg/dose of F-627, 20 mg/dose of F-627 or Filgrastim, in an equal ratio.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 3, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2015

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

August 10, 2015

Last Update Submit

February 22, 2018

Conditions

Neutropenia

Keywords

NeutropeniaMyelotoxic ChemotherapyG-CSF

Outcome Measures

Primary Outcomes (1)

  • The duration of moderate or severe (grade 3 and 4, respectively) neutropenia

    The duration of moderate or severe (grade 3 and 4, respectively) neutropenia post chemotherapy as measure of efficacy of F-627 compared to Filgrastim in female patients wiht breast cance receiving adjuvant chemotherapy.

    In first of 4 cycles (21 days for each cycle) 84 days

Secondary Outcomes (5)

  • The incidence rates of Grade 3 and Grade 4 neutropenia

    up to 4 cycles (84 days)

  • The duration in days of Grade 3 and Grade 4 neutropenia for cycle 2 to 4.

    cycle 2-4 (63 days)

  • The incidence rates of febrile neutropenia

    Up to 4 cycles (84 days)

  • The depth of the ANC nadir

    Up to 4 cycles (84 days)

  • Number of participants with adverse events, changes from baseline of laboratory

    Up to 4 cycles (84 days)

Other Outcomes (1)

  • Immunogenicity of F-627

    Up to 4 cycles (84 days)

Study Arms (3)

F-627, 10 mg/dose

EXPERIMENTAL

F-627 at dose of 10 mg/dose administered by subcutaneous injection on Day 3 of each cycle for up to 4 cycles. EC regimen (Epirubicin and Cyclophosphamide) administered by intravenous injection on Day 1 of each cycle for 4 cycles.

Biological: F-627

F-627, 20 mg/dose

EXPERIMENTAL

F-627 at dose of 20 mg/dose administered by subcutaneous injection on Day 3 of each cycle for up to 4 cycles. EC regimen (Epirubicin and Cyclophosphamide) administered by intravenous injection on Day 1 of each cycle for 4 cycles.

Biological: F-627

Filgrastim, 5 mcg/kg/dose

EXPERIMENTAL

Filgrastim of 5 mcg/dose administered by subcutaneous injection for up to two weeks, start from Day 3 of each cycle for up to 4 cycles. EC regimen (Epirubicin and Cyclophosphamide) administered by intravenous injection on Day 1 of each cycle for 4 cycles.

Biological: Filgrastim

Interventions

F-627BIOLOGICAL

F-627 at doses of 10 mg/dose or 20 mg/dose, s.c. on Day 3 of each cycle for up to 4 cycles.

F-627, 10 mg/doseF-627, 20 mg/dose
FilgrastimBIOLOGICAL

Filgrastim at dose of 5 mcg/kg/day for up to 2 weeks, s.c. start from Day 3 of each cycle for up to 4 cycles.

Also known as: rh G-CSF
Filgrastim, 5 mcg/kg/dose

Eligibility Criteria

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

You may qualify if:

  • Willing to provide written informed consent and to compliant study procedure.
  • years old;
  • Female with breast cancer patients after resection who planned to receive up to 4 cycles of chemotherapy (epirubicin and cyclophosphamide, 100 mg/m2 and 600 mg/m2, respectively).
  • Score 0-2 of East Cooperative Oncology Group (ECOG).
  • Absolute neutrophil count (ANC) ≥ 2.0 × 109/L, hemoglobin (Hb) ≥ 11.0 g/dl, and platelets (PLT) ≥ 100 × 109/L prior to chemotherapy.
  • Liver and kidney function tests were within normal range.
  • Left ventricular ejection fraction (LVEF) \> 50%.
  • If female, subject is either not of childbearing potential, or is of childbearing potential.

You may not qualify if:

  • Patients received radiotherapy within 4 weeks prior to enrollment.
  • Patients received neoadjuvant chemotherapy prior to the resection for breast cancer.
  • Patients received bone marrow or hemopoietic stem cell transplantation.
  • Patient was with malignancy other than breast cancer.
  • Patients received G-CSF treatment within 6 weeks prior to enrollment.
  • Acute congestive heart failure, myocardial disease, or myocardial infarction diagnosed by clinical, electrocardiography, or any other medical procedure.
  • Any disease that possibly cause splenomegaly.
  • Acute infections, chronic active hepatitis B infection within 1 year (except subject with negative hepatitis B antigen prior to enrollment) or history of hepatitis C infection.
  • Pregnancy or lactating women; female with pregnancy potential had positive pregnancy test prior to study treatment.
  • Known the positive result of human immunodeficiency virus (HIV) or patients with acquired immune deficiency syndrome (AIDS).
  • Patients with active tuberculosis (TB), or had ever the history of close contact with patients with TB except negative result in tuberculin test; or under TB treatment; or suspected TB by chest X-ray.
  • Patients with sickle-cell anemia.
  • Patients with alcohol abuse or drug addiction that may affect the compliance of the study.
  • Patients with allergy to proteins extracted from Escherichia coli, G-CSF, or drug excipient.
  • Patients took other investigational products within 1 month or 5 half-lives prior to the enrollment (longer time period is preferred) based on the mechanism of action.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Related Publications (1)

  • Ji D, Wang S, Yao W, Hou D, Wang X, Ye C, Li H, Yang H, Yi J, Lu J, Wang H, Xu X, Cai D, Liu X, Yan X, Nie J, Cui S, Jiang H, Cao J. Efbemalenograstim Alfa, an Fc Fusion Protein, Long-Acting Granulocyte Colony-Stimulating Factor for Reducing the Risk of Chemotherapy-Induced Neutropenia: Results of a Phase II Randomized, Multicenter, Open-Label Trial. Clin Drug Investig. 2025 Nov;45(11):889-899. doi: 10.1007/s40261-025-01479-y. Epub 2025 Oct 9.

    PMID: 41066031DERIVED

MeSH Terms

Conditions

Neutropenia

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Jin Li, Professor

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 13, 2015

Study Start

July 3, 2014

Primary Completion

September 20, 2015

Study Completion

December 22, 2015

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

CN(1)