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Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Hangzhou Jiuyuan Gene Engineering Co. Ltd.,.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01637493
First Posted: July 11, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • Absolute Neutrophil Count (ANC) [ Time Frame: 63 days ]
  • CD34+ Cell count [ Time Frame: 63 days ]
  • Pharmacokinetics: AUC(0-t),Cmax, Tmax, half-life,Cl [ Time Frame: 42 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). [ Time Frame: 63days ]
  • samples for immunogenicity [ Time Frame: days 21,42,63 ]

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Shi Yuankai, M.D. Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  More Information

Publications:
Responsible Party: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
ClinicalTrials.gov Identifier: NCT01637493     History of Changes
Other Study ID Numbers: JY062011A
First Submitted: July 2, 2012
First Posted: July 11, 2012
Last Update Posted: October 12, 2017
Last Verified: July 2012

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