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Trial to Compare the Efficacy and Safety of F-627 and GRAN® (F-627)

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ClinicalTrials.gov Identifier: NCT04174599
Recruitment Status : Completed
First Posted : November 22, 2019
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Generon (Shanghai) Corporation Ltd.

Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE November 22, 2019
Last Update Posted Date November 22, 2019
Actual Study Start Date  ICMJE April 12, 2018
Actual Primary Completion Date January 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2019)
The efficacy of F-627 versus GRAN® in the first cycle of prophylactic treatment in subjects with breast cancer receiving chemotherapy, as assessed by the number of days in which ANC < 1.0 × 109/L in cycle 1 [ Time Frame: At the end of cycle 1(each cycle is 21 days). ]
The primary endpoint is the duration (days) of grade 3 or 4 (moderate and severe) neutropenia in cycle 1, that is, the number of days in which ANC < 1.0 × 109/L in cycle 1.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2019)
  • incidence of grade 3 or 4 neutropenia as assessed by ANC(ANC < 1.0 × 109/L and ANC < 0.5 × 109/L, respectively) [ Time Frame: through study completion, an average of 21 days. ]
    The incidence rate of grade 3 or 4 neutropenia (ANC < 1.0 × 109/L and ANC< 0.5 × 109/L, respectively)
  • durations (days) of grade 3 or 4 neutropenia as assessed by ANC(ANC < 1.0 × 109/L and ANC < 0.5 × 109/L, respectively) [ Time Frame: in cycles 2-4, at the end of cycle 4(each cycle is 21 days.) ]
    The durations (days) of grade 3 or 4 neutropenia (ANC < 1.0 × 109/L and < 0.5 × 109/L, respectively)
  • incidence and duration (days) of grade 4 neutropenia are all as assessed by ANC(ANC < 0.5 × 109/L) [ Time Frame: through study completion, an average of 21 days. ]
    The incidence and duration (days) of grade 4 neutropenia (ANC < 0.5 × 109/L)
  • overall duration (days) of grade 3 or 4 neutropenia as assessed by ANC(ANC < 1.0 × 109/L and ANC < 0.5 ×109/L, respectively) [ Time Frame: through study completion, in overall 4 cycles(each cycle is 21 days). ]
    The overall duration (days) of grade 3 or 4 neutropenia (ANC < 1.0 × 109/L and ANC< 0.5 × 109/L, respectively)
  • The incidence and duration (days) of grade 2 or above neutropenia are all assessed by ANC (ANC < 1.5 × 109/L) [ Time Frame: through study completion, an average of 21 days. ]
    The incidence and duration (days) of grade 2 or above neutropenia (ANC < 1.5 × 109/L) in each cycle.
  • Incidence of febrile neutropenia (FN) (defined as ANC < 1.0×109/L; a single measurement of body temperature > 38.3°C or a temperature ≥ 38.0 °C sustained over 1 h) [ Time Frame: 8 months ]
    Incidence rate of febrile neutropenia (FN) (defined as ANC < 1.0×109/L; a single measurement of body temperature > 38.3 °C or a temperature ≥ 38.0 °C sustained over 1 hr)
  • ANC nadir [ Time Frame: through study completion, an average of 21 days. ]
    The time (days) of ANC nadir recovers to 2.0 × 109/L
  • The neutrophil count nadir from day 3 to day 13 of cycle 1 [ Time Frame: day 3 to day 13 of cycle 1(each cycle is 21 days). ]
    The ANC nadir from day 3 to day 13 of cycle 1
  • the time(days)of ANC nadir returns to 2.0 × 109/L [ Time Frame: through study completion, an average of 21 days. ]
    The time (days) of ANC nadir recovers to 2.0 × 109/L
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 20, 2019)
the potential immunogenicity of F-627 by testing anti-F-627 antibodies inserum [ Time Frame: 8 months ]
To evaluate the immunogenic potential of F-627 by testing serum anti-F-627 antibodies.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Trial to Compare the Efficacy and Safety of F-627 and GRAN®
Official Title  ICMJE A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Trial to Compare the Efficacy and Safety of F-627 and GRAN® in the Prophylactic Treatment for Chemotherapy-Induced Neutropenia
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

Protocol Number: SP11631 Study Stage: Phase III Study Population Female patients with breast cancer will be enrolled to receive at least 4 cycles of EC chemotherapy, that is: epirubicin 100 mg/m2 and cyclophosphamide 600 mg/m2.

Study Design: A multi-center, randomized, open-label, active-controlled phase III clinical trial Site Number: 14 sites(planned) , 12 sites(actual) Subject Number: 240

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Breast Cancer
Intervention  ICMJE Biological: F-627
Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein
Study Arms  ICMJE
  • Experimental: F-627
    Subjects will receive F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ±4 h after the start of chemotherapy.
    Intervention: Biological: F-627
  • Active Comparator: GRAN®
    Subjects will receive GRAN® [5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 ×109/L] on day 3 of each cycle, i.e., 48 ±4 h after the start of chemotherapy.
    Intervention: Biological: F-627
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2019)
242
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 19, 2019
Actual Primary Completion Date January 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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/m2 + cyclophosphamide 600 mg/m2;
  4. ECOG performance status ≤ 2;
  5. Absolute neutrophil count (ANC) ≥ 2.0 × 109/L, hemoglobin (Hb) ≥ 11.0 g/dL, and platelet (PLT) ≥ 100 × 109/L prior to enrollment;
  6. Hepatic and renal functions: Total bilirubin ≤ 1.5 × ULN, ALT and 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: 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/m2 + cyclophosphamide 600 mg/m2;
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04174599
Other Study ID Numbers  ICMJE SP11631
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Generon (Shanghai) Corporation Ltd.
Study Sponsor  ICMJE Generon (Shanghai) Corporation Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zhimin Shao, Doctor Fudan University Shanghai Cancer Centre
PRS Account Generon (Shanghai) Corporation Ltd.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP