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

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Solid Tumor; Lymphoma

Treatments: Drug: Tripegfilgrastim

Study type: Interventional

Funder types: Industry

Identifiers

NCT02963389

DA3031_PNP_I

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: 6 to 19 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 4 patient groups

Tripegfilgrastim 60ug/kg, >=6 and <12-year-old patients

Experimental group

Description:

A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy

Treatment:

Drug: Tripegfilgrastim

Tripegfilgrastim 60ug/kg, >=12 and <19-year-old patients

Experimental group

Description:

A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy

Treatment:

Drug: Tripegfilgrastim

Tripegfilgrastim 100ug/kg, >=6 and <12-year-old patients

Experimental group

Description:

A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy

Treatment:

Drug: Tripegfilgrastim

Tripegfilgrastim 100ug/kg, >=12 and <19-year-old patients

Experimental group

Description:

A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy

Treatment:

Drug: Tripegfilgrastim