Clinical trial NCT04174599: Study to Compare the Efficacy and Safety of F-627 and GRAN®
Official title: A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of F-627 and GRAN® in the Prophylactic Treatment for Chemotherapy-Induced Neutropenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Neutropenia
Lead sponsor: EVIVE Biotechnology
Sponsor class: INDUSTRY
First posted: 2019-11-22
Enrollment: 242
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1
timeFrame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Secondary outcomes:
measure: Number of Participants With Grade 3 or 4 Neutropenia in Cycle 1
timeFrame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Number of Participants With Grade 3 or 4 Neutropenia in Cycle 2
timeFrame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Number of Participants With Grade 3 or 4 Neutropenia in Cycle 3
timeFrame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Number of Participants With Grade 3 or 4 Neutropenia in Cycle 4
timeFrame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Duration of Grade 3 or 4 Neutropenia in Cycle 2
timeFrame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Duration of Grade 3 or 4 Neutropenia in Cycle 3
timeFrame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Duration of Grade 3 or 4 Neutropenia in Cycle 4
timeFrame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Number of Participants With Grade 4 Neutropenia in Cycle 1
timeFrame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Number of Participants With Grade 4 Neutropenia in Cycle 2
timeFrame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Number of Participants With Grade 4 Neutropenia in Cycle 3
timeFrame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Number of Participants With Grade 4 Neutropenia in Cycle 4
timeFrame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Duration of Grade 4 Neutropenia in Cycle 1
timeFrame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Duration of Grade 4 Neutropenia in Cycle 2
timeFrame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Duration of Grade 4 Neutropenia in Cycle 3
timeFrame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Duration of Grade 4 Neutropenia in Cycle 4
timeFrame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Overall Duration of Grade 3 or 4 Neutropenia in 4 Cycles
timeFrame: Overall 4, 21-day chemotherapy cycles(average 12 weeks)
measure: Number of Participants With Grade 2 or Greater Neutropenia in Cycle 1
timeFrame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Number of Participants With Grade 2 or Greater Neutropenia in Cycle 2
timeFrame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Number of Participants With Grade 2 or Greater Neutropenia in Cycle 3
timeFrame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Number of Participants With Grade 2 or Greater Neutropenia in Cycle 4
timeFrame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 1
timeFrame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 2
timeFrame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 3
timeFrame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 4
timeFrame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: The Absolute Neutrophil Counts (ANC) Nadir From Day 3 to Day 13 of Cycle 1
timeFrame: From day 3 to day 13 of cycle 1 (11 days)
measure: Number of Participants With Febrile Neutropenia (FN) in Cycle 1
timeFrame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 1
timeFrame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 2
timeFrame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 3
timeFrame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
measure: Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 4
timeFrame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University Shanghai Cancer Centre
name: Zhimin Shao, Doctor
role: PRINCIPAL_INVESTIGATOR
References: