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

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0002244

Enrollment

Registered

2017-02-27

Start date

2016-10-04

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : A single dose of Tripegfilgrastim 60ug/kg or 100ug/kg is administered subcutaneously to &gt

=6 and &lt

19-year-old pediatrics with solid tumor/lymphoma 24hr after completion of chemotherapy. Sixteen patients are assigned to each age group. Half the 16 aged &gt

12 years are given Tripegfilgrastim 60 µg/kg and the other 8 patients receive 100 µg/kg. Of 16 aged &gt

=12 and &lt

19 years, 8 patients receive Tripegfilgrastim 60 µg/kg and the other 8 patients receive 100 µg/kg.

Eligibility

Sex/Gender

All

Inclusion 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> < 0.5 x 10^9/L • ANC > 0.75 x 10^9/L, platelet > 75 x 10^9/L • ECOG performance status 0 or 1

Exclusion criteria

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
Tmax, Cmax, AUClast, T1/2, Ctrough	—

Secondary

Measure	Time frame
ANCmax, AUC(ANC), Tmax(ANC);Safety parameter(Adeverse event(AE), Vital sign, Clinical laboratory testing of blood(hematology and biochemistry) and urine(urinanalysis), ECG)	—

Countries

Korea, Republic of

Contacts

Public ContactHyoung Kang

Seoul National University Hospital

01026@snuh.org+82-2-2072-3452

Outcome results