A Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim in Pediatric Solid Tumor/Lymphoma Patients

Study Overview
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Brief Summary
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This is an open-label, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma patients

Official Title
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A Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim After Single Administration in Pediatric Solid Tumor/Lymphoma Patients

Conditions
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Lymphoma, Solid Tumor

Intervention / Treatment
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* Drug: Tripegfilgrastim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >=6 and <19-year-old pediatrics with solid tumor/lymphoma Scheduled for chemotherapy requiring G-CSF support or having given an experience of ANC < 0.5x10^9/L ANC > 0.75x10^9/L, platelet > 75x10^9/L ECOG performance status 0 or 1 Exclusion Criteria: Patients with leukemia, myelodysplastic syndrome or uncontrolled infectious/nervous diseases History of allergy to filgrastim, pegfilgrastim or known hypersensitivity to E-coli derived proteins. Women who are pregnant or lactating

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tripegfilgrastim 60ug/kg, >=6 and <12-year-old patients<br>A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy | Drug: Tripegfilgrastim<br> <br> * Other names: DA-3031;|
| Experimental: Tripegfilgrastim 60ug/kg, >=12 and <19-year-old patients<br>A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy | Drug: Tripegfilgrastim<br> <br> * Other names: DA-3031;|
| Experimental: Tripegfilgrastim 100ug/kg, >=6 and <12-year-old patients<br>A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy | Drug: Tripegfilgrastim<br> <br> * Other names: DA-3031;|
| Experimental: Tripegfilgrastim 100ug/kg, >=12 and <19-year-old patients<br>A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy | Drug: Tripegfilgrastim<br> <br> * Other names: DA-3031;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameter | Time to reach Cmax of Tripegfilgrastim [Tmax] | Day 1(Hour 0)   Day 21 | 
| PK parameter | Peak plasma concentration of Tripegfilgrastim [Cmax] | Day 1(Hour 0)   Day 21 | 
| PK parameter | Area under the plasma concentration of Tripegfilgrastim versus time curve [AUC] | Day 1(Hour 0)   Day 21 | 
| PK parameter | Half-life of Tripegfilgrastim [T1/2] | Day 1(Hour 0)   Day 21 | 
| PK parameter | The lowest plasma concentration that Tripegfilgrastim reaches before the next dose is administered [Ctrough] | Day 1(Hour 0)   Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD parameter | Peak plasma concentration of Absolute Neutrophil Count [ANCmax] | Day 1(Hour 0)   Day 14 | 
| PD parameter | Area under the plasma concentration of Absolute Neutrophil Count versus time curve [AUC(ANC)] | Day 1(Hour 0)   Day 14 | 
| PD parameter | Time to reach Cmax of Absolute Neutrophil Count [Tmax(ANC)] | Day 1(Hour 0)   Day 14 |