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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02963389

Enrollment

Registered

2016-11-15

Start date

2016-10-04

Completion date

2018-11-30

Last updated

2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Solid Tumor

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

Interventions

DRUGTripegfilgrastim

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 19 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
PK parameter	Day 1(Hour 0) ~ Day 21	Time to reach Cmax of Tripegfilgrastim \[Tmax\]

Secondary

Measure	Time frame	Description
PD parameter	Day 1(Hour 0) ~ Day 14	Peak plasma concentration of Absolute Neutrophil Count \[ANCmax\]

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026