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

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A ST Co., Ltd.

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