Clinical trial NCT01637493: Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients
Official title: Safety,Tolerability,Pharmacokinetics and Pharmacodynamics Phase 1 Study of Pegfilgrastim in Chemotherapy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Neutropenia
Keywords: Pegylation
G-CSF
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Sponsor class: INDUSTRY
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2012-07-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Blood concentration of pegfilgrastim for pharmacokinetics
timeFrame: 42 days
Secondary outcomes:
measure: Absolute Neutrophil Count (ANC)
timeFrame: 63 days
measure: CD34+ Cell count
timeFrame: 63 days
measure: Pharmacokinetics: AUC(0-t),Cmax, Tmax, half-life,Cl
timeFrame: 42 days
measure: 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).
timeFrame: 63days
measure: samples for immunogenicity
timeFrame: days 21,42,63
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Shi Yuankai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1177/0091270006288731.
citation: 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. doi: 10.1200/JCO.2000.18.13.2522.