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Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients

Primary Purpose

Neutropenia

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Pegfilgrastim
Pegfilgrastim
Pegfilgrastim
Pegfilgrastim
Sponsored by
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neutropenia focused on measuring Pegylation, G-CSF, Pharmacokinetics, Pharmacodynamics

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Pegfilgrastim, 30mcg/kg

Pegfilgrastim, 60mcg/kg

Pegfilgrastim, 100mcg/kg

Pegfilgrastim, 200mcg/kg

Arm Description

Outcomes

Primary Outcome Measures

Blood concentration of pegfilgrastim for pharmacokinetics

Secondary Outcome Measures

Absolute Neutrophil Count (ANC)
CD34+ Cell count
Pharmacokinetics: AUC(0-t),Cmax, Tmax, half-life,Cl
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).
samples for immunogenicity

Full Information

First Posted
July 2, 2012
Last Updated
July 10, 2012
Sponsor
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01637493
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia
Keywords
Pegylation, G-CSF, Pharmacokinetics, Pharmacodynamics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pegfilgrastim, 30mcg/kg
Arm Type
Experimental
Arm Title
Pegfilgrastim, 60mcg/kg
Arm Type
Experimental
Arm Title
Pegfilgrastim, 100mcg/kg
Arm Type
Experimental
Arm Title
Pegfilgrastim, 200mcg/kg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pegfilgrastim
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pegfilgrastim
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pegfilgrastim
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pegfilgrastim
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood concentration of pegfilgrastim for pharmacokinetics
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Absolute Neutrophil Count (ANC)
Time Frame
63 days
Title
CD34+ Cell count
Time Frame
63 days
Title
Pharmacokinetics: AUC(0-t),Cmax, Tmax, half-life,Cl
Time Frame
42 days
Title
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
Title
samples for immunogenicity
Time Frame
days 21,42,63

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi Yuankai, M.D.
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shi Yuankai, M.D.
Phone
8610-87788701
First Name & Middle Initial & Last Name & Degree
Qin Yan, M.D.
Phone
8610-87788507
Email
qinyan66@vip.sina.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
16809800
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.
Results Reference
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PubMed Identifier
10893282
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.
Results Reference
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Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients

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