Trial Outcomes & Findings for Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer (NCT NCT01569087)
NCT ID: NCT01569087
Last Updated: 2016-12-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
21 days
Results posted on
2016-12-05
Participant Flow
Participant milestones
| Measure |
Empegfilgrastim 3 mg
Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Empegfilgrastim 6 mg
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Filgrastim
Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
19
|
|
Overall Study
COMPLETED
|
20
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer
Baseline characteristics by cohort
| Measure |
Empegfilgrastim 3 mg
n=21 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Empegfilgrastim 6 mg
n=20 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Filgrastim
n=19 Participants
Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
54.0 years
n=5 Participants
|
53.5 years
n=7 Participants
|
48.7 years
n=5 Participants
|
53.5 years
n=4 Participants
|
|
Gender
Female
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
19 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Duration of a disease
|
0.8 months
n=5 Participants
|
0.6 months
n=7 Participants
|
0.5 months
n=5 Participants
|
0.65 months
n=4 Participants
|
|
Histologic type of a breast cancer
ductal
|
15 participants
n=5 Participants
|
11 participants
n=7 Participants
|
15 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Histologic type of a breast cancer
lobular
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Histologic type of a breast cancer
ductal/lobular
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Histologic type of a breast cancer
medullar
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Histologic type of a breast cancer
no data
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Expression of hormone receptors
estrogen receptors
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Expression of hormone receptors
estrogen and progesterone receptors
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
7 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Expression of hormone receptors
deficiency estrogen and progesterone receptors
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Expression of hormone receptors
no data
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
HER2 expression
1+
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
HER2 expression
2+
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
HER2 expression
3+
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
HER2 expression
deficiency HER2 expression
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
5 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
HER2 expression
no data
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
History previous therapy of breast cancer
yes
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
History previous therapy of breast cancer
no
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
46 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 \[expected time of nadir\] were excluded from analysis)
Outcome measures
| Measure |
Empegfilgrastim 3 mg
n=21 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Empegfilgrastim 6 mg
n=20 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Filgrastim
n=18 Participants
Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
|
|---|---|---|---|
|
CTCAE Grade 3/4 Neutropenia Incidence
|
18 participants
|
13 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 \[expected time of nadir\] were excluded from analysis)
Outcome measures
| Measure |
Empegfilgrastim 3 mg
n=21 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Empegfilgrastim 6 mg
n=20 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Filgrastim
n=18 Participants
Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
|
|---|---|---|---|
|
Mean Duration of CTCAE Grade 4 Neutropenia
|
0.43 days
Standard Deviation 0.50
|
0.40 days
Standard Deviation 0.49
|
0.33 days
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 \[expected time of nadir\] were excluded from analysis)
Outcome measures
| Measure |
Empegfilgrastim 3 mg
n=21 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Empegfilgrastim 6 mg
n=20 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Filgrastim
n=18 Participants
Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
|
|---|---|---|---|
|
The Duration of Any Grade Neutropenia
|
1.86 days
Standard Deviation 1.39
|
1.0 days
Standard Deviation 0.79
|
0.78 days
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 \[expected time of nadir\] were excluded from analysis)
Outcome measures
| Measure |
Empegfilgrastim 3 mg
n=21 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Empegfilgrastim 6 mg
n=20 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Filgrastim
n=18 Participants
Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
|
|---|---|---|---|
|
Low Level (Nadir) ANC x 10^9/L
|
0.57 cells x 10^9/L
Interval 0.3 to 0.73
|
0.75 cells x 10^9/L
Interval 0.28 to 1.32
|
0.82 cells x 10^9/L
Interval 0.4 to 1.89
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 \[expected time of nadir\] were excluded from analysis)
Outcome measures
| Measure |
Empegfilgrastim 3 mg
n=21 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Empegfilgrastim 6 mg
n=20 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Filgrastim
n=18 Participants
Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
|
|---|---|---|---|
|
Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy
|
4.8 days
Standard Deviation 1.64
|
3.8 days
Standard Deviation 2.04
|
3.00 days
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 \[expected time of nadir\] were excluded from analysis)
Outcome measures
| Measure |
Empegfilgrastim 3 mg
n=21 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Empegfilgrastim 6 mg
n=20 Participants
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Filgrastim
n=18 Participants
Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
|
|---|---|---|---|
|
Incidence of Febrile Neutropenia
|
1 participants
|
1 participants
|
0 participants
|
Adverse Events
Empegfilgrastim 3 mg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Empegfilgrastim 6 mg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Filgrastim
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Empegfilgrastim 3 mg
n=21 participants at risk
Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Empegfilgrastim 6 mg
n=20 participants at risk
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Filgrastim
n=19 participants at risk
Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
neutropenia grade 4
|
0.00%
0/21 • 1 month
|
0.00%
0/20 • 1 month
|
10.5%
2/19 • Number of events 2 • 1 month
|
Other adverse events
| Measure |
Empegfilgrastim 3 mg
n=21 participants at risk
Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Empegfilgrastim 6 mg
n=20 participants at risk
Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy
empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
|
Filgrastim
n=19 participants at risk
Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy
filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
neutropenia grade 3
|
42.9%
9/21 • Number of events 9 • 1 month
|
30.0%
6/20 • Number of events 6 • 1 month
|
31.6%
6/19 • Number of events 6 • 1 month
|
|
Blood and lymphatic system disorders
neutropenia grade 4
|
42.9%
9/21 • Number of events 9 • 1 month
|
45.0%
9/20 • Number of events 9 • 1 month
|
36.8%
7/19 • Number of events 7 • 1 month
|
|
Blood and lymphatic system disorders
anemia
|
57.1%
12/21 • Number of events 12 • 1 month
|
60.0%
12/20 • Number of events 12 • 1 month
|
78.9%
15/19 • Number of events 15 • 1 month
|
|
Blood and lymphatic system disorders
white blood cells decreased
|
100.0%
21/21 • Number of events 21 • 1 month
|
95.0%
19/20 • Number of events 19 • 1 month
|
89.5%
17/19 • Number of events 17 • 1 month
|
|
Blood and lymphatic system disorders
Trombocitopenia
|
52.4%
11/21 • Number of events 11 • 1 month
|
60.0%
12/20 • Number of events 12 • 1 month
|
31.6%
6/19 • Number of events 6 • 1 month
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
4.8%
1/21 • Number of events 1 • 1 month
|
5.0%
1/20 • Number of events 1 • 1 month
|
0.00%
0/19 • 1 month
|
|
Endocrine disorders
hiperglicemia
|
71.4%
15/21 • Number of events 15 • 1 month
|
80.0%
16/20 • Number of events 16 • 1 month
|
84.2%
16/19 • Number of events 16 • 1 month
|
|
Hepatobiliary disorders
ALT decreased
|
38.1%
8/21 • Number of events 8 • 1 month
|
30.0%
6/20 • Number of events 6 • 1 month
|
26.3%
5/19 • Number of events 5 • 1 month
|
|
Hepatobiliary disorders
Alcaline Phosphotase decreased
|
9.5%
2/21 • Number of events 2 • 1 month
|
10.0%
2/20 • Number of events 2 • 1 month
|
31.6%
6/19 • Number of events 6 • 1 month
|
|
General disorders
alopecia
|
38.1%
8/21 • Number of events 8 • 1 month
|
55.0%
11/20 • Number of events 11 • 1 month
|
63.2%
12/19 • Number of events 12 • 1 month
|
|
General disorders
nousea
|
14.3%
3/21 • Number of events 3 • 1 month
|
35.0%
7/20 • Number of events 7 • 1 month
|
26.3%
5/19 • Number of events 5 • 1 month
|
|
General disorders
fatigue
|
33.3%
7/21 • Number of events 7 • 1 month
|
40.0%
8/20 • Number of events 8 • 1 month
|
36.8%
7/19 • Number of events 7 • 1 month
|
|
Musculoskeletal and connective tissue disorders
ossalgia
|
14.3%
3/21 • Number of events 3 • 1 month
|
15.0%
3/20 • Number of events 3 • 1 month
|
15.8%
3/19 • Number of events 3 • 1 month
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/21 • 1 month
|
5.0%
1/20 • Number of events 1 • 1 month
|
0.00%
0/19 • 1 month
|
|
General disorders
headache
|
0.00%
0/21 • 1 month
|
5.0%
1/20 • Number of events 1 • 1 month
|
0.00%
0/19 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place