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The primary objective of this study is to find the optimal dose of balugrastim by characterizing its pharmacokinetics (PK), and by comparing the pharmacodynamics (PD) of balugrastim to filgrastim in children receiving chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balugrastim 300 ug/kg | Experimental | Balugrastim 300 μg/kg subcutaneously (SC) administration once per chemotherapy cycle, approximately 24 h after chemotherapy, up to 4 cycles |
|
| Balugrastim 670 μg/kg | Experimental | Balugrastim 670 μg/kg (maximum 40 mg) SC administration once per chemotherapy cycle, approximately 24 h after chemotherapy, up to 4 cycles |
|
| Filgrastim 5 μg/kg | Active Comparator | Filgrastim will be administered at a dose of 5 μg/kg SC once a day for at least 5 consecutive days or until absolute neutrophil count (ANC) has returned to ≥2*10^9/L for each chemotherapy cycle up to 4 cycles. The maximum period of filgrastim administration is 14 days in each cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balugrastim | Drug | Balugrastim 300 ug/kg and Balugrastim 670 ug/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of absolute neutrophil count (ANC) | Day 1 to 14 |
| Measure | Description | Time Frame |
|---|---|---|
| ANC nadir | ANC nadir (measured in 10^9/L), which is the lowest ANC recorded | Baseline to Week 16 |
| Time to ANC nadir | Time to ANC nadir, which is the time from the beginning of chemotherapy up to the occurrence of the ANC nadir |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C000600093 | balugrastim |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| Filgrastim | Drug | Filgrastim 5 μg/kg |
|
| Baseline to Week 16 |
| Time to ANC recovery | Time to ANC recovery (ANC >1.5*10^9/L) from nadir within each treatment cycle | Baseline to Week 16 |
| Duration of severe neutropenia (DSN) | Number of days subject experiences severe neutropenia (ANC <0.5*10^9/L) | Baseline to Week 16 |
| Incidence of severe neutropenia | Proportion of subjects who experience severe neutropenia (ANC <0.5*10^9/L) | Baseline to Week 16 |
| Frequency of febrile neutropenia | Frequency of febrile neutropenia (defined as body temperature >38.5°C for more than one hour [axillary measurement] and ANC <0.5*10^9/L) by cycle and across all cycles. | Baseline to Week 16 |
| Summary of Participants with Adverse Events | From signing of informed consent to 16 weeks |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |