Study to Compare the Efficacy and Safety of F-627 and GRAN®

NCT ID: NCT04174599

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-12
• Study Completion Date: 2019-06-19

Brief Summary

A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Trial to Compare the Efficacy and Safety of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein (F-627) and Recombinant Human Granulocyte Colony Stimulating Factor (GRAN®) in the Prophylactic Treatment for Chemotherapy-Induced Neutropenia

Detailed Description

Study Stage: Phase III

Study Population: Female patients with breast cancer will be enrolled to receive at least 4 cycles of Epirubicin + Cyclophosphamide (EC) chemotherapy, that is: epirubicin 100 mg/m^2 and cyclophosphamide 600 mg/m^2.

Study Design: A multi-center, randomized, open-label, active-controlled phase III clinical trial

Conditions

Breast Cancer; Neutropenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

F-627

F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy

Group Type: EXPERIMENTAL

F-627

Intervention Type: DRUG

Day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy

GRAN®

GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy

Group Type: ACTIVE_COMPARATOR

GRAN®

Intervention Type: DRUG

Since day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy, continuous treatment for ≤ 2 weeks or until ANC recovers to 5.0 × 10\^9/L from nadir (investigators may refer to ANC test results from the Department of Laboratory Medicine of each study sites to decide when to discontinue GRAN®)

Interventions

F-627

Day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy

Intervention Type: DRUG

GRAN®

Since day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy, continuous treatment for ≤ 2 weeks or until ANC recovers to 5.0 × 10\^9/L from nadir (investigators may refer to ANC test results from the Department of Laboratory Medicine of each study sites to decide when to discontinue GRAN®)

Intervention Type: DRUG

Other Intervention Names

Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein; Filgrastim

Eligibility Criteria

Inclusion Criteria

1. Willing to sign the informed consent form and able to comply with protocol requirements;

2. 18-75 years old;

3. Female postoperative patients with breast cancer who require adjuvant chemotherapy, and are planned to receive at least 4 cycles of EC chemotherapy, namely epirubicin 100 mg/m^2 + cyclophosphamide 600 mg/m^2;

4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;

5. Absolute neutrophil count (ANC) ≥ 2.0 × 10^9/L, hemoglobin (Hb) ≥ 11.0 g/dL, and platelet (PLT) ≥ 100 × 10^9/L prior to enrollment;

6. Hepatic and renal functions: Total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, serum creatinine ≤ 1.5 × ULN;

7. Left ventricular ejection fraction > 50%;

8. Women without child-bearing potential, i.e., women who have had menopause for at least 1 year or who have undergone sterilization (bilateral tubal ligation, double oophorectomy or hysterectomy); patients with child-bearing potential should agree to take appropriate contraceptive measures, including condoms, spermicidal condoms, foams, gels, contraceptive barrier, intrauterine devices (IUD), and contraceptives (oral or injection), starting from 1 month before the start of the study until 30 days after the end of the study.

Exclusion Criteria

1. Radiation therapy within 4 weeks prior to enrollment;

2. Patients with breast cancer who have received neoadjuvant chemotherapy before surgery;

3. Prior bone marrow or stem cell transplant;

4. With other malignant tumors other than breast cancer;

5. Patients who have received a treatment with recombinant human granulocyte colony stimulating factor within 6 weeks prior to randomization;

6. Diagnosed with acute congestive heart failure, cardiomyopathy, or myocardial infarction by clinical diagnosis, ECG or other approaches;

7. With any disease that may cause splenomegaly;

8. With acute infection, chronic active Hepatitis B within 1 year (unless patients tested negative for HBsAg prior to enrollment), or Hepatitis C;

9. Women in pregnancy or breastfeeding;

10. Known HIV positive or AIDS;

11. With active tuberculosis (TB); history of TB exposure, unless negative for tuberculin test; TB patients undergoing treatment; or suspected TB evaluated by chest x-ray;

12. With sickle cell anemia;

13. With alcohol or drug abuse that may affect the compliance with the study;

14. With known hypersensitivity to granulocyte colony stimulating factor or excipients;

15. Have received any other investigational drug within 1 month or 5 half-lives of the investigational drugs prior to enrollment (whichever is longer);

16. Patients with diseases or symptoms unsuitable for participating in the trial. For example, the study drugs may compromise the health of the patient or the assessment of adverse events may be affected.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

EVIVE Biotechnology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhimin Shao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Fudan University Shanghai Cancer Centre

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

References

Zhang Q, Wang Z, Yao W, Wang S, Zhang G, Chen J, Hou Q, Li S, Li H, Ye C, Sun T, Yang H, Chen Z, Wang Z, Liu X, Geng C, Li X, Zhang J, Zheng H, Shao Z. A randomized, multicenter phase III Study of once-per-cycle administration of efbemalenograstim alfa (F-627), a novel long-acting rhG-CSF, for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer. BMC Cancer. 2024 Sep 13;24(1):1143. doi: 10.1186/s12885-024-12892-5.

Reference Type: DERIVED

PMID: 39272058 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SP11631

Identifier Type: -

Identifier Source: org_study_id