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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
        • Contact:
          • Shi Yuankai, M.D.
          • Phone Number: 8610-87788701
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pegfilgrastim, 30mcg/kg
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
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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood concentration of pegfilgrastim for pharmacokinetics
Time Frame: 42 days
42 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Shi Yuankai, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

July 2, 2012

First Submitted That Met QC Criteria

July 10, 2012

First Posted (Estimate)

July 11, 2012

Study Record Updates

Last Update Posted (Estimate)

July 11, 2012

Last Update Submitted That Met QC Criteria

July 10, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • JY062011A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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