Pegteograstim in Children With Solid Tumors

Efficacy and Safety of Pegteograstim on Chemotherapy-induced Neutropenia in Children With Solid Tumors

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02787876

Enrollment

Registered

2016-06-01

Start date

2016-10-04

Completion date

2018-11-30

Last updated

2018-09-18

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

Conditions

Chemotherapy Induced Neutropenia, Pediatric Solid Tumor

Brief summary

To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors

Detailed description

Children with solid tumor experience neutropenia after cytotoxic chemotherapy, and they usually receive granulocyte colony-stimulating factor (G-CSF) to stimulate neutrophil recovery. However it needs daily injection of G-CSF. Pegteograstim is a new formulation of PEGylated recombinant human G-CSF analogue pegfilgrastim. In this study, investigators aimed to evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors.

Interventions

DRUGPegteograstim

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

Inclusion criteria

* Patients with solid tumor who undergo chemotherapy with carboplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen

Exclusion criteria

* Patients with organ dysfunction (creatinine \> 2mg/dL, ejection fraction \<40% or severe arrhythmia/conduction disorder, other severe organ dysfunction) * Hypersensitivity to pegteograstim, protein originated from E-coli, pegfilgrastim, filgrastim or latex. * Patients with bleeding tendency to whom subcutaneous injection should be avoided. * Active infection or infectious fever during the screening period. * Genetic problem to fructose tolerance. * Patients who participated in other clinical trial within 4 weeks before enrollment. * Pregnant and nursing women

Design outcomes

Primary

Measure	Time frame
Rate of adverse events	Up to 3 weeks after the injection of pegteograsim
Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL)	Up to 6 weeks

Secondary

Measure	Time frame
Duration of severe neutropenia (ANC < 100/uL)	Up to 6 weeks
Lowest value of ANC	Up to 6 weeks
Days with neutropenic fever	Up to 6 weeks

Countries

South Korea

Contacts

Primary ContactKi Woong Sung, MD, PhD

kiwoong.sung@samsung.com82-2-3410-3529

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026