Trial Outcomes & Findings for Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy (NCT NCT02527746)
NCT ID: NCT02527746
Last Updated: 2024-02-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Up to 4 cycles (about 84 days)
Results posted on
2024-02-23
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Baseline characteristics by cohort
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
49.0 years
STANDARD_DEVIATION 4.90 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 9.17 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
18 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 4 cycles (about 84 days)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.
Outcome measures
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
|---|---|---|---|
|
Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy.
Number of subjects who reported AEs
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy.
Number of subjects who reported TEAEs
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy.
Number of subjects who reported investigational drug-related TEAEs
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy.
Number of subjects who reported grade 3 or greater TEAEs
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy.
Number of subjects who reported grade 3 or greater investigational drug-related TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy.
Number of subjects who reported TEAEs leading to permanent discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy.
Number of subjects who reported serious adverse events (SAEs)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy.
Number of subjects who reported of investigational drug-related serious adverse events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 21 daysTolerability 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).
Outcome measures
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
|---|---|---|---|
|
Tolerability (Dose-limiting Toxicity) of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy.
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 and cycle 3 (each cycle was about 21 days)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).
Outcome measures
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
|---|---|---|---|
|
T1/2 of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Cycle 1 T1/2
|
49.88 hours
Interval 38.71 to 76.67
|
34.71 hours
Interval 19.39 to 86.05
|
56.37 hours
Interval 31.14 to 112.95
|
|
T1/2 of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Cycle 3 T1/2
|
73.44 hours
Interval 55.28 to 210.58
|
61.95 hours
Interval 45.79 to 131.79
|
44.58 hours
Interval 31.05 to 109.27
|
SECONDARY outcome
Timeframe: Cycle 1 and cycle 3 (each cycle was about 21 days)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.
Outcome measures
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
|---|---|---|---|
|
Cmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Cycle 1 Cmax
|
25.77 ng/mL
Standard Deviation 7.22
|
226.80 ng/mL
Standard Deviation 101.70
|
192.87 ng/mL
Standard Deviation 76.06
|
|
Cmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Cycle 3 Cmax
|
29.06 ng/mL
Standard Deviation 27.53
|
73.09 ng/mL
Standard Deviation 26.16
|
85.17 ng/mL
Standard Deviation 46.71
|
SECONDARY outcome
Timeframe: Cycle 1 and cycle 3 (each cycle was about 21 days)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.
Outcome measures
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
|---|---|---|---|
|
Tmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Cycle 1 Tmax
|
24 hours
Interval 12.0 to 36.0
|
36.00 hours
Interval 12.0 to 48.0
|
48.15 hours
Interval 24.3 to 120.2
|
|
Tmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Cycle 3 Tmax
|
12.00 hours
Interval 5.8 to 12.0
|
9.10 hours
Interval 6.0 to 24.2
|
12.00 hours
Interval 11.5 to 12.0
|
SECONDARY outcome
Timeframe: Cycle 1 and cycle 3 (each cycle was about 21 days)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.
Outcome measures
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
|---|---|---|---|
|
Area Under Curve (AUC)0-t of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Cycle 1 Area Under Curve (AUC)
|
2477.75 h*ng/mL
Standard Deviation 661.64
|
15230.79 h*ng/mL
Standard Deviation 4851.43
|
19858.38 h*ng/mL
Standard Deviation 7503.75
|
|
Area Under Curve (AUC)0-t of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Cycle 3 Area Under Curve (AUC)
|
1586.35 h*ng/mL
Standard Deviation 632.57
|
4347.35 h*ng/mL
Standard Deviation 2135.28
|
6556.98 h*ng/mL
Standard Deviation 2683.3
|
SECONDARY outcome
Timeframe: Cycle 1 and cycle 3 (each cycle was about 21 days)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.
Outcome measures
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
|---|---|---|---|
|
Vz/F of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Cycle 1 Vz/F
|
2457.22 mL/kg
Standard Deviation 975.35
|
1238.80 mL/kg
Standard Deviation 1336.92
|
1597.02 mL/kg
Standard Deviation 646.10
|
|
Vz/F of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Cycle 3 Vz/F
|
6196.75 mL/kg
Standard Deviation 3477.13
|
6132.23 mL/kg
Standard Deviation 2997.45
|
4079.81 mL/kg
Standard Deviation 2189.98
|
SECONDARY outcome
Timeframe: Cycle 1 and cycle 3 (each cycle was about 21 days)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.
Outcome measures
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
|---|---|---|---|
|
Cl/F of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Cycle 1 Cl/F
|
31.34 mL/h/kg
Standard Deviation 7.14
|
17.11 mL/h/kg
Standard Deviation 6.94
|
18.89 mL/h/kg
Standard Deviation 9.78
|
|
Cl/F of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Cycle 3 Cl/F
|
45.41 mL/h/kg
Standard Deviation 16.47
|
62.45 mL/h/kg
Standard Deviation 35.67
|
56.38 mL/h/kg
Standard Deviation 26.24
|
SECONDARY outcome
Timeframe: Cycle 1 and cycle 3 (each cycle was about 21 days)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.
Outcome measures
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
|---|---|---|---|
|
Mean Residence Time (MRT)0-t of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Cycle 1 Mean residence time (MRT)
|
86.85 hours
Standard Deviation 11.70
|
61.98 hours
Standard Deviation 18.90
|
88.69 hours
Standard Deviation 18.73
|
|
Mean Residence Time (MRT)0-t of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Cycle 3 Mean residence time (MRT)
|
87.08 hours
Standard Deviation 18.97
|
75.61 hours
Standard Deviation 7.44
|
96.29 hours
Standard Deviation 25.61
|
SECONDARY outcome
Timeframe: Up to 4 cycles (84 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.
Outcome measures
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Grade 3 or 4 Neutropenia (< 1.0 × 10^9/L)
Percentage of subjects with grade 3 or 4 neutropenia (%) in cycle 1
|
6 Participants
|
3 Participants
|
5 Participants
|
|
Percentage of Subjects With Grade 3 or 4 Neutropenia (< 1.0 × 10^9/L)
Percentage of subjects with grade 3 or 4 neutropenia (%) in cycle 2
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Percentage of Subjects With Grade 3 or 4 Neutropenia (< 1.0 × 10^9/L)
Percentage of subjects with grade 3 or 4 neutropenia (%) in cycle 3
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Percentage of Subjects With Grade 3 or 4 Neutropenia (< 1.0 × 10^9/L)
Percentage of subjects with grade 3 or 4 neutropenia (%) in cycle 4
|
4 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 4 cycles (84 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.
Outcome measures
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
|---|---|---|---|
|
Percentage of Subjects With Grade 4 Neutropenia (< 0.5 × 10^9/L)
Percentage of subjects with grade 4 neutropenia (%) in cycle 1
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Percentage of Subjects With Grade 4 Neutropenia (< 0.5 × 10^9/L)
Percentage of subjects with grade 4 neutropenia (%) in cycle 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects With Grade 4 Neutropenia (< 0.5 × 10^9/L)
Percentage of subjects with grade 4 neutropenia (%) in cycle 3
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Percentage of Subjects With Grade 4 Neutropenia (< 0.5 × 10^9/L)
Percentage of subjects with grade 4 neutropenia (%) in cycle 4
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 4 cycles (84 days)Population: 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.
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.
Outcome measures
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
|---|---|---|---|
|
Duration of Absolute Neutrophil Count (ANC)< 0.5 × 10^9/L (Days)
Duration of ANC < 0.5 × 10^9/L (days) in cycle 1
|
0.8 days
Standard Deviation 0.98
|
1.2 days
Standard Deviation 1.33
|
0.5 days
Standard Deviation 0.84
|
|
Duration of Absolute Neutrophil Count (ANC)< 0.5 × 10^9/L (Days)
Duration of ANC < 0.5 × 10^9/L (days) in cycle 2
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Duration of Absolute Neutrophil Count (ANC)< 0.5 × 10^9/L (Days)
Duration of ANC < 0.5 × 10^9/L (days) in cycle 3
|
0 days
Standard Deviation 0
|
0.2 days
Standard Deviation 0.41
|
0 days
Standard Deviation 0
|
|
Duration of Absolute Neutrophil Count (ANC)< 0.5 × 10^9/L (Days)
Duration of ANC < 0.5 × 10^9/L (days) in cycle 4
|
0.3 days
Standard Deviation 0.52
|
0.3 days
Standard Deviation 0.52
|
0 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Up to 4 cycles (84 days)Population: 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.
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.
Outcome measures
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
|---|---|---|---|
|
Duration of Absolute Neutrophil Count (ANC)< 1.0 × 10^9/L (Days)
Duration of ANC < 1.0 × 10^9/L (days) in cycle 1
|
2.8 days
Standard Deviation 0.75
|
1.5 days
Standard Deviation 1.76
|
1.5 days
Standard Deviation 1.05
|
|
Duration of Absolute Neutrophil Count (ANC)< 1.0 × 10^9/L (Days)
Duration of ANC < 1.0 × 10^9/L (days) in cycle 2
|
0 days
Standard Deviation 0
|
0.3 days
Standard Deviation 0.52
|
0 days
Standard Deviation 0
|
|
Duration of Absolute Neutrophil Count (ANC)< 1.0 × 10^9/L (Days)
Duration of ANC < 1.0 × 10^9/L (days) in cycle 3
|
0.7 days
Standard Deviation 0.82
|
0.3 days
Standard Deviation 0.52
|
0.2 days
Standard Deviation 0.41
|
|
Duration of Absolute Neutrophil Count (ANC)< 1.0 × 10^9/L (Days)
Duration of ANC < 1.0 × 10^9/L (days) in cycle 4
|
1.0 days
Standard Deviation 1.10
|
0.7 days
Standard Deviation 1.03
|
0.5 days
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Up to 4 cycles (84 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.
Outcome measures
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
|---|---|---|---|
|
Absolute Neutrophil Count (ANC) Nadir (10^9 Cells/L)
ANC Nadir (10^9/L) in cycle 1
|
0.50 10^9 cells/L
Standard Deviation 0.352
|
0.90 10^9 cells/L
Standard Deviation 1.056
|
0.72 10^9 cells/L
Standard Deviation 0.360
|
|
Absolute Neutrophil Count (ANC) Nadir (10^9 Cells/L)
ANC Nadir (10^9/L) in cycle 2
|
1.57 10^9 cells/L
Standard Deviation 0.339
|
1.97 10^9 cells/L
Standard Deviation 1.193
|
2.33 10^9 cells/L
Standard Deviation 0.841
|
|
Absolute Neutrophil Count (ANC) Nadir (10^9 Cells/L)
ANC Nadir (10^9/L) in cycle 3
|
1.52 10^9 cells/L
Standard Deviation 0.833
|
2.42 10^9 cells/L
Standard Deviation 2.260
|
2.20 10^9 cells/L
Standard Deviation 0.976
|
|
Absolute Neutrophil Count (ANC) Nadir (10^9 Cells/L)
ANC Nadir (10^9/L) in cycle 4
|
0.87 10^9 cells/L
Standard Deviation 0.589
|
2.02 10^9 cells/L
Standard Deviation 1.551
|
1.63 10^9 cells/L
Standard Deviation 0.862
|
SECONDARY outcome
Timeframe: Up to 4 cycles (84 days)Population: 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.
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.
Outcome measures
| Measure |
F-627 80 µg/kg
n=6 Participants
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.
|
F-627 240 µg/kg
n=6 Participants
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.
|
F-627 320 µg/kg
n=6 Participants
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.
|
|---|---|---|---|
|
Time (Days) of Absolute Neutrophil Count (ANC) Recovered to 1.0 × 10^9/L From Nadir
Time (days) of ANC recovered to 1.0 × 10^9/L from nadir in cycle 1
|
2.5 days
Standard Deviation 0.55
|
1.2 days
Standard Deviation 1.47
|
1.0 days
Standard Deviation 0.63
|
|
Time (Days) of Absolute Neutrophil Count (ANC) Recovered to 1.0 × 10^9/L From Nadir
Time (days) of ANC recovered to 1.0 × 10^9/L from nadir in cycle 2
|
0.0 days
Standard Deviation 0.00
|
0.7 days
Standard Deviation 1.03
|
0.0 days
Standard Deviation 0.00
|
|
Time (Days) of Absolute Neutrophil Count (ANC) Recovered to 1.0 × 10^9/L From Nadir
Time (days) of ANC recovered to 1.0 × 10^9/L from nadir in cycle 3
|
1.3 days
Standard Deviation 1.63
|
0.7 days
Standard Deviation 1.03
|
0.3 days
Standard Deviation 0.82
|
|
Time (Days) of Absolute Neutrophil Count (ANC) Recovered to 1.0 × 10^9/L From Nadir
Time (days) of ANC recovered to 1.0 × 10^9/L from nadir in cycle 4
|
1.0 days
Standard Deviation 0.89
|
0.7 days
Standard Deviation 1.03
|
0.7 days
Standard Deviation 1.03
|
Adverse Events
F-627 80 µg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
F-627 240 µg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
F-627 320 µg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
F-627 80 µg/kg
n=6 participants at risk
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.
|
F-627 240 µg/kg
n=6 participants at risk
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.
|
F-627 320 µg/kg
n=6 participants at risk
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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
febrile neutropenia
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
Other adverse events
| Measure |
F-627 80 µg/kg
n=6 participants at risk
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.
|
F-627 240 µg/kg
n=6 participants at risk
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.
|
F-627 320 µg/kg
n=6 participants at risk
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.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
2/6 • Number of events 2 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
3/6 • Number of events 3 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Number of events 4 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
33.3%
2/6 • Number of events 2 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 2 • 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
|
0.00%
0/6 • 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
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
33.3%
2/6 • Number of events 2 • 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
|
50.0%
3/6 • Number of events 3 • 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
|
0.00%
0/6 • 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
|
|
Skin and subcutaneous tissue disorders
Pigmentation Disorder
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
6/6 • Number of events 10 • 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
|
83.3%
5/6 • Number of events 9 • 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
|
100.0%
6/6 • Number of events 8 • 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
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
33.3%
2/6 • Number of events 2 • 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
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
General disorders
Asthenia
|
83.3%
5/6 • Number of events 9 • 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
|
33.3%
2/6 • Number of events 2 • 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
|
0.00%
0/6 • 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
|
|
General disorders
Fatigue
|
83.3%
5/6 • Number of events 9 • 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
|
83.3%
5/6 • Number of events 13 • 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
|
100.0%
6/6 • Number of events 13 • 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
|
|
General disorders
Effusion
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
General disorders
Chest Discomfort
|
33.3%
2/6 • Number of events 2 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Gastrointestinal disorders
Constipation
|
100.0%
6/6 • Number of events 12 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Gastrointestinal disorders
Gingival Bleeding
|
33.3%
2/6 • Number of events 3 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Gastrointestinal disorders
Gingival Swelling
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Gastrointestinal disorders
Nausea
|
100.0%
6/6 • Number of events 17 • 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
|
83.3%
5/6 • Number of events 15 • 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
|
83.3%
5/6 • Number of events 16 • 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
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • Number of events 2 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • 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
|
33.3%
2/6 • Number of events 2 • 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
|
0.00%
0/6 • 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
|
|
Gastrointestinal disorders
Dry Mouth
|
50.0%
3/6 • Number of events 5 • 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
|
0.00%
0/6 • 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
|
33.3%
2/6 • Number of events 3 • 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
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Gastrointestinal disorders
Mouth Ulceration
|
33.3%
2/6 • Number of events 2 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Investigations
Aspartate Aminotransferase Increased
|
16.7%
1/6 • Number of events 3 • 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
|
16.7%
1/6 • Number of events 2 • 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
|
0.00%
0/6 • 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
|
|
Investigations
Electrocardiogram change
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
33.3%
2/6 • Number of events 2 • 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
|
|
Injury, poisoning and procedural complications
Wound Complication
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Investigations
Haemoglobin Decreased
|
100.0%
6/6 • Number of events 32 • 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
|
100.0%
6/6 • Number of events 64 • 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
|
66.7%
4/6 • Number of events 31 • 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
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Investigations
Platelet Count Decreased
|
33.3%
2/6 • Number of events 9 • 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
|
66.7%
4/6 • Number of events 19 • 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
|
83.3%
5/6 • Number of events 21 • 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
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 3 • 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
|
50.0%
3/6 • Number of events 3 • 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
|
0.00%
0/6 • 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
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
33.3%
2/6 • Number of events 5 • 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
|
33.3%
2/6 • Number of events 3 • 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
|
33.3%
2/6 • Number of events 3 • 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
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
66.7%
4/6 • Number of events 5 • 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
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
33.3%
2/6 • Number of events 2 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • 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
|
33.3%
2/6 • Number of events 3 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
General disorders
Pain
|
0.00%
0/6 • 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
|
33.3%
2/6 • Number of events 2 • 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
|
0.00%
0/6 • 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
|
|
General disorders
Oedema Peripheral
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
100.0%
6/6 • Number of events 14 • 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
|
100.0%
6/6 • Number of events 16 • 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
|
100.0%
6/6 • Number of events 19 • 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
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
|
Infections and infestations
Incision site infection
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Investigations
White Blood Cell Count Decreased
|
100.0%
6/6 • Number of events 71 • 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
|
100.0%
6/6 • Number of events 41 • 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
|
100.0%
6/6 • Number of events 32 • 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
|
|
Investigations
Alanine Aminotransferase Increased
|
16.7%
1/6 • Number of events 3 • 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
|
16.7%
1/6 • Number of events 2 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 2 • 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
|
|
Investigations
White blood cells urine positive
|
33.3%
2/6 • Number of events 2 • 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
|
0.00%
0/6 • 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
|
50.0%
3/6 • Number of events 3 • 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
|
|
Investigations
Protein urine present
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Investigations
Blood urine present
|
50.0%
3/6 • Number of events 4 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Investigations
Neutrophil Count Decreased
|
100.0%
6/6 • Number of events 56 • 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
|
83.3%
5/6 • Number of events 33 • 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
|
100.0%
6/6 • Number of events 23 • 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
|
|
Gastrointestinal disorders
Vomiting
|
83.3%
5/6 • Number of events 19 • 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
|
83.3%
5/6 • Number of events 20 • 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
|
83.3%
5/6 • Number of events 14 • 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
|
|
Gastrointestinal disorders
Haematemesis
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
|
Gastrointestinal disorders
Gingival inflammation
|
33.3%
2/6 • Number of events 4 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Cardiac disorders
Extrasystoles
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Cardiac disorders
Ventricular extrasystoles
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Cardiac disorders
Palpitations
|
83.3%
5/6 • Number of events 6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Vascular disorders
Phlebitis
|
33.3%
2/6 • Number of events 2 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Eye disorders
Eye pruritus
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
33.3%
2/6 • Number of events 3 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place