Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Hangzhou Jiuyuan Gene Engineering Co. Ltd.,.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
ClinicalTrials.gov Identifier:
NCT01637493
First received: July 2, 2012
Last updated: July 10, 2012
Last verified: July 2012

July 2, 2012
July 10, 2012
February 2012
February 2013   (final data collection date for primary outcome measure)
Blood concentration of pegfilgrastim for pharmacokinetics [ Time Frame: 42 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01637493 on ClinicalTrials.gov Archive Site
  • Absolute Neutrophil Count (ANC) [ Time Frame: 63 days ] [ Designated as safety issue: No ]
  • CD34+ Cell count [ Time Frame: 63 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics: AUC(0-t),Cmax, Tmax, half-life,Cl [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: 63days ] [ Designated as safety issue: Yes ]
  • samples for immunogenicity [ Time Frame: days 21,42,63 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients
Safety,Tolerability,Pharmacokinetics and Pharmacodynamics Phase 1 Study of Pegfilgrastim in Chemotherapy Patients

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neutropenia
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.
  • Experimental: Pegfilgrastim, 30mcg/kg
    Intervention: Drug: Pegfilgrastim
  • Experimental: Pegfilgrastim, 60mcg/kg
    Intervention: Drug: Pegfilgrastim
  • Experimental: Pegfilgrastim, 100mcg/kg
    Intervention: Drug: Pegfilgrastim
  • Experimental: Pegfilgrastim, 200mcg/kg
    Intervention: Drug: Pegfilgrastim

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
June 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
China
 
NCT01637493
JY062011A
No
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Principal Investigator: Shi Yuankai, M.D. Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP