- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01637493
Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients
July 10, 2012 updated by: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
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
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
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Beijing, Beijing, China, 100021
- Recruiting
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Shi Yuankai, M.D.
- Phone Number: 8610-87788701
-
Contact:
- Qin Yan, M.D.
- Phone Number: 8610-87788507
- Email: qinyan66@vip.sina.com
-
-
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.
General Publications
- 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.
- 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.
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
Keywords
Additional Relevant MeSH Terms
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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