Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients

Neutropenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01637493
• Other study ID #: JY062011A
• Status: Unknown status
• Phase: Phase 1
• First received: July 2, 2012
• Last updated: July 10, 2012
• Start date: February 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2012
• Source: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 24
• Est. completion date: June 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Neutropenia

Intervention

Drug:
• Pegfilgrastim
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.
• Pegfilgrastim
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.
• Pegfilgrastim
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.
• Pegfilgrastim
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.

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (2)

Johnston E, Crawford J, Blackwell S, Bjurstrom T, Lockbaum P, Roskos L, Yang BB, Gardner S, Miller-Messana MA, Shoemaker D, Garst J, Schwab G. Randomized, dose-escalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy. J Clin Oncol. 2000 Jul;18(13):2522-8. — View Citation

Roskos LK, Lum P, Lockbaum P, Schwab G, Yang BB. Pharmacokinetic/pharmacodynamic modeling of pegfilgrastim in healthy subjects. J Clin Pharmacol. 2006 Jul;46(7):747-57. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood concentration of pegfilgrastim for pharmacokinetics		42 days
Secondary	Absolute Neutrophil Count (ANC)		63 days
Secondary	CD34+ Cell count		63 days
Secondary	Pharmacokinetics: AUC(0-t),Cmax, Tmax, half-life,Cl		42 days
Secondary	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
Secondary	samples for immunogenicity		days 21,42,63