Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients

NCT01637493 | Unknown Phase 1

• 1 other identifier: JY062011A
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neutropenia

Keywords

Pegylation; G-CSF; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Blood concentration of pegfilgrastim for pharmacokinetics

  42 days

Secondary Outcomes (5)

• Absolute Neutrophil Count (ANC)

  63 days

• CD34+ Cell count

  63 days

• Pharmacokinetics: AUC(0-t),Cmax, Tmax, half-life,Cl

  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).

  63days

• samples for immunogenicity

  days 21,42,63

Study Arms (4)

Pegfilgrastim, 30mcg/kg

EXPERIMENTAL

Drug: Pegfilgrastim

Pegfilgrastim, 60mcg/kg

EXPERIMENTAL

Drug: Pegfilgrastim

Pegfilgrastim, 100mcg/kg

EXPERIMENTAL

Drug: Pegfilgrastim

Pegfilgrastim, 200mcg/kg

EXPERIMENTAL

Drug: Pegfilgrastim

Interventions

Pegfilgrastim DRUG

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.

Pegfilgrastim, 30mcg/kg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hangzhou Jiuyuan Gene Engineering Co. Ltd.,: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 16809800 BACKGROUND

• 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.

  PMID: 10893282 BACKGROUND

MeSH Terms

Conditions

Neutropenia

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Shi Yuankai, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 11, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 11, 2012

Record last verified: 2012-07

Locations

CN (1)