Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients

Study Overview
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Brief Summary
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The purpose of this study is to examine the safety,tolerability,pharmacokinetics and pharmacodynamics of Pegfilgrastim in patients with chemotherapy-induced neutropenia.

Official Title
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Safety,Tolerability,Pharmacokinetics and Pharmacodynamics Phase 1 Study of Pegfilgrastim in Chemotherapy Patients

Conditions
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Neutropenia

Intervention / Treatment
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* Drug: Pegfilgrastim
* Drug: Pegfilgrastim
* Drug: Pegfilgrastim
* Drug: Pegfilgrastim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegfilgrastim, 30mcg/kg<br> | Drug: Pegfilgrastim<br>* 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.<br>|
| Experimental: Pegfilgrastim, 60mcg/kg<br> | Drug: Pegfilgrastim<br>* 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.<br>|
| Experimental: Pegfilgrastim, 100mcg/kg<br> | Drug: Pegfilgrastim<br>* 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.<br>|
| Experimental: Pegfilgrastim, 200mcg/kg<br> | Drug: Pegfilgrastim<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood concentration of pegfilgrastim for pharmacokinetics |  | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pegylation, Pharmacokinetics, Pharmacodynamics, G-CSF