Overview

Pegteograstim in Children With Solid Tumors

Status:
Unknown status
Trial end date:
2018-11-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
Collaborator:
Green Cross Corporation
Criteria
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