A Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim After Single Administration in Pediatric Solid Tumor/Lymphoma Patients
Overview
- Phase
- Phase 1
- Intervention
- Tripegfilgrastim
- Conditions
- Solid Tumor
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- PK parameter
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is an open-label, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma patients
Investigators
Eligibility Criteria
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
Arms & Interventions
Tripegfilgrastim 60ug/kg, >=6 and <12-year-old patients
A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
Intervention: Tripegfilgrastim
Tripegfilgrastim 60ug/kg, >=12 and <19-year-old patients
A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
Intervention: Tripegfilgrastim
Tripegfilgrastim 100ug/kg, >=6 and <12-year-old patients
A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy
Intervention: Tripegfilgrastim
Tripegfilgrastim 100ug/kg, >=12 and <19-year-old patients
A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy
Intervention: Tripegfilgrastim
Outcomes
Primary Outcomes
PK parameter
Time Frame: Day 1(Hour 0) ~ Day 21
The lowest plasma concentration that Tripegfilgrastim reaches before the next dose is administered \[Ctrough\]
Secondary Outcomes
- PD parameter(Day 1(Hour 0) ~ Day 14)