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Pegteograstim in Children With Solid Tumors

Samsung Medical Center logo

Samsung Medical Center

Status and phase

Unknown
Phase 2

Conditions

Pediatric Solid Tumor
Chemotherapy Induced Neutropenia

Treatments

Drug: Pegteograstim

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02787876
2015-12-121

Details and patient eligibility

About

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

Full 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.

Enrollment

34 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 1 patient group

Chemotherapy induced neutropenia
Experimental group
Description:
Pegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle
Treatment:
Drug: Pegteograstim

Trial contacts and locations

1

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Central trial contact

Ki Woong Sung, MD, PhD

Data sourced from clinicaltrials.gov

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