Pegteograstim in Children With Solid Tumors

Phase 2

• Conditions: Chemotherapy Induced Neutropenia; Pediatric Solid Tumor
• Interventions: Drug: Pegteograstim

• Registration Number: NCT02787876
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-06-01
• Study Start: 2016-10-04
• Status Verified: 2017-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-18
• Primary Completion: 2018-10
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy induced neutropenia	Pegteograstim	Pegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of