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

Phase 1

Completed

• Conditions: Lymphoma; Solid Tumor
• Interventions: Drug: Tripegfilgrastim

• Registration Number: NCT02963389
• Lead Sponsor: Dong-A ST Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-04
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-15
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-13
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tripegfilgrastim 60ug/kg, >=6 and <12-year-old patients	Tripegfilgrastim	A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
Tripegfilgrastim 100ug/kg, >=12 and <19-year-old patients	Tripegfilgrastim	A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy
Tripegfilgrastim 60ug/kg, >=12 and <19-year-old patients	Tripegfilgrastim	A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
Tripegfilgrastim 100ug/kg, >=6 and <12-year-old patients	Tripegfilgrastim	A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy

Primary Outcome Measures

Name	Time	Method
PK parameter	Day 1(Hour 0) ~ Day 21	The lowest plasma concentration that Tripegfilgrastim reaches before the next dose is administered \[Ctrough\]

Secondary Outcome Measures

Name	Time	Method
PD parameter	Day 1(Hour 0) ~ Day 14	Time to reach Cmax of Absolute Neutrophil Count \[Tmax(ANC)\]

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of