Pegteograstim in Children With Solid Tumors

Pediatric Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02787876
• Other study ID #: 2015-12-121
• Status: Recruiting
• Phase: Phase 2
• Start date: October 4, 2016
• Est. completion date: November 2018

Study information

• Verified date: September 2017
• Source: Samsung Medical Center
• Contact: Ki Woong Sung, MD, PhD
• Phone: 82-2-3410-3529
• Email: kiwoong.sung[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: November 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy Induced Neutropenia
• Neutropenia
• Pediatric Solid Tumor

Intervention

Drug:
• Pegteograstim

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of adverse events		Up to 3 weeks after the injection of pegteograsim
Primary	Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL)		Up to 6 weeks
Secondary	Duration of severe neutropenia (ANC < 100/uL)		Up to 6 weeks
Secondary	Lowest value of ANC		Up to 6 weeks
Secondary	Days with neutropenic fever		Up to 6 weeks