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| Name | Class |
|---|---|
| Fudan University | OTHER |
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A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up to 4 cycles of Epirubicin and Cyclophosphamide. 18 patients (6 patients each cohort) were assigned to three escalated dose cohorts of 80, 240 and 320 µg/kg.
A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients receiving 4 cycles of EC (Epirubicin plus Cyclophosphamide) chemotherapy.
18 patients (6 patients each cohort) were assigned to three sequential doses cohort of F-627 at the dose of 80, 240 and 320 µg/kg. The patients received chemotherapy (100 mg/m^2 epirubicin and 600 mg/m^2 cyclophosphamide) administrated by i.v. injection on Day 1 and F-627 by s.c. injection on Day 3 of each cycle for 4 cycles. If no dose-limiting toxicity (DLT) was observed in 6 patients during first cycle, the next cohort was escalated.
Blood samples were collected for completed blood counts with differential, serum F-627 concentration and safety evaluation at different point following F-672 injection.
The decision to proceed to the next higher dose was made jointly by the sponsor's medical expert and the investigator based upon the review of safety data in the first cycle treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F-627 80 µg/kg | Experimental | F-627 at the dose of 80 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. |
|
| F-627 240 µg/kg | Experimental | F-627 at the dose of 240 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. |
|
| F-627 320 µg/kg | Experimental | F-627 at the dose of 320 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-627 | Drug | F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy. | Safety endpoints include incidence rate and severity of adverse events (AEs), laboratory measurements, physical examinations, vital signs, and performance status. Severity of AEs were assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.03 criteria. | Up to 4 cycles (about 84 days) |
| Tolerability (Dose-limiting Toxicity) of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy. | Tolerability should be assessed by dose-limiting toxicity (DLT). DLT is defined as any grade 3 or greater adverse event related to the investigational drug that observed in cycle 1 (21 days). | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| T1/2 of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 | There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using enzyme linked immunosorbent assay (ELISA). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junning Cao, Professor | Fudan University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | F-627 80 µg/kg | F-627 at the dose of 80 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. F-627: F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used. Epirubicin+Cyclophosphamide (EC) regimen: Epirubicin 100 mg/m^2 (in vein) and Cyclophosphamide 600 mg/m^2 (in vein) on Day 1 of each cycle for 4 cycles. |
| FG001 | F-627 240 µg/kg | F-627 at the dose of 240 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. F-627: F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used. EC regimen: Epirubicin 100 mg/m^2 (in vein) and Cyclophosphamide 600 mg/m^2 (in vein) on Day 1 of each cycle for 4 cycles. |
| FG002 | F-627 320 µg/kg | F-627 at the dose of 320 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. F-627: F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used. EC regimen: Epirubicin 100 mg/m^2 (in vein) and Cyclophosphamide 600 mg/m^2 (in vein) on Day 1 of each cycle for 4 cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | F-627 80 µg/kg | F-627 at the dose of 80 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. F-627: F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used. EC regimen: Epirubicin 100 mg/m^2 (in vein) and Cyclophosphamide 600 mg/m^2 (in vein) on Day 1 of each cycle for 4 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy. | Safety endpoints include incidence rate and severity of adverse events (AEs), laboratory measurements, physical examinations, vital signs, and performance status. Severity of AEs were assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.03 criteria. | Posted | Count of Participants | Participants | Up to 4 cycles (about 84 days) |
|
From the first treatment of chemotherapy until the end of study at Day 84
Summary of Adverse Events includes only those participants who received at least one dose of investigational product
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | F-627 80 µg/kg | F-627 at the dose of 80 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. F-627: F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used. EC regimen: Epirubicin 100 mg/m^2 (in vein) and Cyclophosphamide 600 mg/m^2 (in vein) on Day 1 of each cycle for 4 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| febrile neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catrina Wang / Senior Medical Director | Evivebiotech | 021-61760866 | catrina.wang@evivebiotech.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 13, 2013 | Apr 13, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2013 | May 3, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C098534 | EC regimen |
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|
| EC regimen | Drug | Epirubicin 100 mg/m^2 (in vein) and Cyclophosphamide 600 mg/m^2 (in vein) on Day 1 of each cycle for 4 cycles. |
|
|
| Cycle 1 and cycle 3 (each cycle was about 21 days) |
| Cmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 | There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA. | Cycle 1 and cycle 3 (each cycle was about 21 days) |
| Tmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 | There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA. | Cycle 1 and cycle 3 (each cycle was about 21 days) |
| Area Under Curve (AUC)0-t of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 | There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA. | Cycle 1 and cycle 3 (each cycle was about 21 days) |
| Vz/F of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 | There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA. | Cycle 1 and cycle 3 (each cycle was about 21 days) |
| Cl/F of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 | There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA. | Cycle 1 and cycle 3 (each cycle was about 21 days) |
| Mean Residence Time (MRT)0-t of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 | There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA. | Cycle 1 and cycle 3 (each cycle was about 21 days) |
| Percentage of Subjects With Grade 3 or 4 Neutropenia (< 1.0 × 10^9/L) | For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle. | Up to 4 cycles (84 days) |
| Percentage of Subjects With Grade 4 Neutropenia (< 0.5 × 10^9/L) | For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle. | Up to 4 cycles (84 days) |
| Duration of Absolute Neutrophil Count (ANC)< 0.5 × 10^9/L (Days) | For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle. | Up to 4 cycles (84 days) |
| Duration of Absolute Neutrophil Count (ANC)< 1.0 × 10^9/L (Days) | For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle. | Up to 4 cycles (84 days) |
| Absolute Neutrophil Count (ANC) Nadir (10^9 Cells/L) | For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle. | Up to 4 cycles (84 days) |
| Time (Days) of Absolute Neutrophil Count (ANC) Recovered to 1.0 × 10^9/L From Nadir | For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle. | Up to 4 cycles (84 days) |
| BG001 |
| F-627 240 µg/kg |
F-627 at the dose of 240 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. F-627: F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used. EC regimen: Epirubicin 100 mg/m^2 (in vein) and Cyclophosphamide 600 mg/m^2 (in vein) on Day 1 of each cycle for 4 cycles. |
| BG002 | F-627 320 µg/kg | F-627 at the dose of 320 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. F-627: F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used. EC regimen: Epirubicin 100 mg/m^2 (in vein) and Cyclophosphamide 600 mg/m^2 (in vein) on Day 1 of each cycle for 4 cycles. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | F-627 240 µg/kg | F-627 at the dose of 240 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. F-627: F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used. EC regimen: Epirubicin 100 mg/m^2 (in vein) and Cyclophosphamide 600 mg/m^2 (in vein) on Day 1 of each cycle for 4 cycles. |
| OG002 | F-627 320 µg/kg | F-627 at the dose of 320 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. F-627: F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used. EC regimen: Epirubicin 100 mg/m^2 (in vein) and Cyclophosphamide 600 mg/m^2 (in vein) on Day 1 of each cycle for 4 cycles. |
|
|
| Primary | Tolerability (Dose-limiting Toxicity) of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy. | Tolerability should be assessed by dose-limiting toxicity (DLT). DLT is defined as any grade 3 or greater adverse event related to the investigational drug that observed in cycle 1 (21 days). | Posted | Count of Participants | Participants | Up to 21 days |
|
|
|
| Secondary | T1/2 of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 | There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using enzyme linked immunosorbent assay (ELISA). | Posted | Median | Full Range | hours | Cycle 1 and cycle 3 (each cycle was about 21 days) |
|
|
|
| Secondary | Cmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 | There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 and cycle 3 (each cycle was about 21 days) |
|
|
|
| Secondary | Tmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 | There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA. | Posted | Median | Full Range | hours | Cycle 1 and cycle 3 (each cycle was about 21 days) |
|
|
|
| Secondary | Area Under Curve (AUC)0-t of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 | There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA. | Posted | Mean | Standard Deviation | h*ng/mL | Cycle 1 and cycle 3 (each cycle was about 21 days) |
|
|
|
| Secondary | Vz/F of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 | There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA. | Posted | Mean | Standard Deviation | mL/kg | Cycle 1 and cycle 3 (each cycle was about 21 days) |
|
|
|
| Secondary | Cl/F of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 | There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA. | Posted | Mean | Standard Deviation | mL/h/kg | Cycle 1 and cycle 3 (each cycle was about 21 days) |
|
|
|
| Secondary | Mean Residence Time (MRT)0-t of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 | There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA. | Posted | Mean | Standard Deviation | hours | Cycle 1 and cycle 3 (each cycle was about 21 days) |
|
|
|
| Secondary | Percentage of Subjects With Grade 3 or 4 Neutropenia (< 1.0 × 10^9/L) | For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle. | Posted | Count of Participants | Participants | Up to 4 cycles (84 days) |
|
|
|
| Secondary | Percentage of Subjects With Grade 4 Neutropenia (< 0.5 × 10^9/L) | For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle. | Posted | Count of Participants | Participants | Up to 4 cycles (84 days) |
|
|
|
| Secondary | Duration of Absolute Neutrophil Count (ANC)< 0.5 × 10^9/L (Days) | For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle. | This outcome measure applies to all participants with a valid ANC level, regardless of whether the ANC level is less than 0.5 × 10^9/L. The value of 0 represents the participant experienced 0 days with ANC < 0.5 × 10^9/L (days). The Number of Participants Analyzed for *each* Row is the same with the Overall Number of Participants Analyzed. | Posted | Mean | Standard Deviation | days | Up to 4 cycles (84 days) |
|
|
|
| Secondary | Duration of Absolute Neutrophil Count (ANC)< 1.0 × 10^9/L (Days) | For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle. | This outcome measure applies to all participants with a valid ANC level, regardless of whether the ANC level is less than 1.0 × 10^9/L. The value of 0 represents the participant experienced 0 days with ANC < 1.0 × 10^9/L (days). The Number of Participants Analyzed for *each* Row is the same with the Overall Number of Participants Analyzed. | Posted | Mean | Standard Deviation | days | Up to 4 cycles (84 days) |
|
|
|
| Secondary | Absolute Neutrophil Count (ANC) Nadir (10^9 Cells/L) | For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle. | Posted | Mean | Standard Deviation | 10^9 cells/L | Up to 4 cycles (84 days) |
|
|
|
| Secondary | Time (Days) of Absolute Neutrophil Count (ANC) Recovered to 1.0 × 10^9/L From Nadir | For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle. | This outcome measure applies to all participants with a valid ANC level, regardless of whether the ANC level is less than 1.0 × 10^9/L. The value of 0 represents the participant experienced 0 days with ANC recovered to 1.0 × 10^9/L from nadir. The Number of Participants Analyzed for *each* Row is the same with the Overall Number of Participants Analyzed. | Posted | Mean | Standard Deviation | days | Up to 4 cycles (84 days) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | F-627 240 µg/kg | F-627 at the dose of 240 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. F-627: F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used. EC regimen: Epirubicin 100 mg/m^2 (in vein) and Cyclophosphamide 600 mg/m^2 (in vein) on Day 1 of each cycle for 4 cycles. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG002 | F-627 320 µg/kg | F-627 at the dose of 320 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. F-627: F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used. EC regimen: Epirubicin 100 mg/m^2 (in vein) and Cyclophosphamide 600 mg/m^2 (in vein) on Day 1 of each cycle for 4 cycles. | 0 | 6 | 0 | 6 | 6 | 6 |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Musculoskeletal Discomfort | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Incision site infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| White Blood Cell Count Decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Electrocardiogram change | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Haemoglobin Decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Blood phosphorus increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Wound Complication | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Limb Discomfort | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pigmentation Disorder | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Effusion | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Gingival Bleeding | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Gingival Swelling | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Mouth Haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Mouth Ulceration | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Gingival inflammation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (16.0) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (16.0) | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA (16.0) | Systematic Assessment |
|
Not provided
Not provided
| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
|
|
|
|
|
|
|
|
| Percentage of subjects with grade 3 or 4 neutropenia (%) in cycle 3 |
|
| Percentage of subjects with grade 3 or 4 neutropenia (%) in cycle 4 |
|
|
| Percentage of subjects with grade 4 neutropenia (%) in cycle 3 |
|
| Percentage of subjects with grade 4 neutropenia (%) in cycle 4 |
|
|
| Duration of ANC < 0.5 × 10^9/L (days) in cycle 3 |
|
| Duration of ANC < 0.5 × 10^9/L (days) in cycle 4 |
|
|
| Duration of ANC < 1.0 × 10^9/L (days) in cycle 3 |
|
| Duration of ANC < 1.0 × 10^9/L (days) in cycle 4 |
|
|
| ANC Nadir (10^9/L) in cycle 3 |
|
| ANC Nadir (10^9/L) in cycle 4 |
|
|
| Time (days) of ANC recovered to 1.0 × 10^9/L from nadir in cycle 3 |
|
| Time (days) of ANC recovered to 1.0 × 10^9/L from nadir in cycle 4 |
|