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

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

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

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