Neutropenia
Conditions
Keywords
Pegylation, G-CSF, Pharmacokinetics, Pharmacodynamics
Brief summary
The purpose of this study is to examine the safety,tolerability,pharmacokinetics and pharmacodynamics of Pegfilgrastim in patients with chemotherapy-induced neutropenia.
Interventions
DRUGPegfilgrastim
Single SC injection of the appropriate dose of drug ranging from 30 mcg/kg to 200 mcg/kg at postchemotherapy 48hr in cycle 2, followed by two doses SC injection of the appropriate dose of drug ranging from 15 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 3.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18～70 years * Confirmed malignant tumor patients by histopathological or cytological diagnosis, not previously treated with chemotherapy or radiotherapy,suitable for chemotherapy with carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin * Karnofsky score ≥ 70 * Normal coagulation function, no evidences of hemorrhage,WBC ≥ 3,500 per cubic milliliter, ANC ≥ 1,500 per cubic milliliter, PLT ≥ 100,000 per cubic milliliter * Normal liver, heart, kidney function * Life expectancy \> 3 months * Signed informed consent
Exclusion criteria
* Not adequately controlled infections(e.g. ANC ≥ 12,000 per cubic milliliter,temperature \> 38.2℃) * Evidence of metastatic disease in bone marrow,or with other malignant tumors * Subjects with symptomatic brain metastases * Pregnant or breast-feeding or in menstrual period females * Participated more than 3 clinical trials in nearly a year(as subjects) * Currently participated in any other clinical trials,or Used any prescription medication could impact on the metabolism of investigational drug, or participated in any other clinical trial within one month from the date of the screening visit * Donation of whole blood or a unit of blood within three months prior to the start of study * Known hypersensitivity to filgrastim or any of the products to be administered during dosing * Evidence of, or treatment for, drug or alcohol abuse within one year from date of screening visit * Other conditions which in the opinion of the investigator preclude enrollment into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration of pegfilgrastim for pharmacokinetics | 42 days |
Secondary
| Measure | Time frame |
|---|---|
| Absolute Neutrophil Count (ANC) | 63 days |
| CD34+ Cell count | 63 days |
| Pharmacokinetics: AUC(0-t),Cmax, Tmax, half-life,Cl | 42 days |
| Safety data: including physical examinations ( include injection site reactions) , laboratory evaluations( ECGs, AST, ALT, Cr, BUN, hemostasis and coagulation test, electrolyte test ), vital signs assessments, and adverse effects (AEs). | 63days |
| samples for immunogenicity | days 21,42,63 |
Countries
China
Outcome results
None listed