A Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim in Pediatric Solid Tumor/Lymphoma Patients
Not Applicable
Recruiting
- Conditions
- Neoplasms
- Registration Number
- KCT0002244
- Lead Sponsor
- Dong-A ST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
• >=6 and <19 year-old pediatrics with solid tumor/lymphoma • Scheduled for chemotherapy requiring G-CSF support or having given an experience of ANC> < 0.5 x 10^9/L
• ANC > 0.75 x 10^9/L, platelet > 75 x 10^9/L
• ECOG performance status 0 or 1
Exclusion Criteria
• Patients with leukemia, myelodysplastic syndrome or uncontrolled infectious/nervous diseases
• History of allergy to filgrastim, pegfilgrastim or known hypersensitivity to E-coli derived proteins
• Women who are pregnant or lactating
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tmax, Cmax, AUClast, T1/2, Ctrough
- Secondary Outcome Measures
Name Time Method ANCmax, AUC(ANC), Tmax(ANC);Safety parameter(Adeverse event(AE), Vital sign, Clinical laboratory testing of blood(hematology and biochemistry) and urine(urinanalysis), ECG)