Text Size

Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients

This study is currently recruiting participants.
Verified July 2012 by Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Sponsor:
Collaborator:
Cancer Institute and Hospital, CAMS
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
History of Changes
  Purpose

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


Condition Intervention Phase
Neutropenia
 Drug: Pegfilgrastim
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety,Tolerability,Pharmacokinetics and Pharmacodynamics Phase 1 Study of Pegfilgrastim in Chemotherapy Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hangzhou Jiuyuan Gene Engineering Co. Ltd.,:

Primary Outcome Measures:
  • Blood concentration of pegfilgrastim for pharmacokinetics [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: February 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegfilgrastim, 30mcg/kg 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, 60mcg/kg 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, 100mcg/kg 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, 200mcg/kg 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637493

Locations
China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Shi Yuankai, M.D.     8610-87788701        
Contact: Qin Yan, M.D.     8610-87788507     qinyan66@vip.sina.com    
Sponsors and Collaborators
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Cancer Institute and Hospital, CAMS
Investigators
Principal Investigator: Shi Yuankai, M.D. Cancer Institute and Hospital, CAMS
  More Information

Publications:

Responsible Party: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
ClinicalTrials.gov Identifier: NCT01637493     History of Changes
Other Study ID Numbers: JY062011A
Study First Received: July 2, 2012
Last Updated: July 10, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Hangzhou Jiuyuan Gene Engineering Co. Ltd.,:
Pegylation
G-CSF
Pharmacokinetics
Pharmacodynamics

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013