Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients

Phase 1

• Conditions: Neutropenia
• Interventions: Drug: Pegfilgrastim

• Registration Number: NCT01637493
• Lead Sponsor: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Status Verified: 2012-07
• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-10
• Last Update Submitted: 2012-07-10
• Study First Posted: 2012-07-11
• Last Update Posted: 2012-07-11
• Primary Completion: 2013-02
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pegfilgrastim, 200mcg/kg	Pegfilgrastim	-
Pegfilgrastim, 30mcg/kg	Pegfilgrastim	-
Pegfilgrastim, 60mcg/kg	Pegfilgrastim	-
Pegfilgrastim, 100mcg/kg	Pegfilgrastim	-

Primary Outcome Measures

Name	Time	Method
Blood concentration of pegfilgrastim for pharmacokinetics	42 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: AUC(0-t),Cmax, Tmax, half-life,Cl	42 days
Absolute Neutrophil Count (ANC)	63 days
CD34+ Cell count	63 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

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China