A Randomized, Open-label, Single-dose, Dose-escalation, Self-controlled Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of YPEG-Filgrastim in Cancer Patients Receiving Chemotherapy

Xiamen Amoytop Biotech Co., Ltd.1 site in 1 country30 target enrollmentApril 2010

ConditionsChemotherapy Patients

InterventionsYPEG-Filgrastim

DrugsYPEG-Filgrastim

Overview

Phase: Phase 1
Intervention: YPEG-Filgrastim
Conditions: Chemotherapy Patients
Sponsor: Xiamen Amoytop Biotech Co., Ltd.
Enrollment: 30
Locations: 1
Primary Endpoint: Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish dose-response relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER).

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

November 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Xiamen Amoytop Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age: 18～70yrs
•Signed informed consent
•Confirmed malignant tumor patients by histopathological or cytological diagnosis, suitable for chemotherapy with carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin
•Karnofsky score ≥70
•Life expectancy \>3 months
•WBC≥3,500 per cubic milliliter, ANC≥1,500 per cubic milliliter, PLT≥100,000 per cubic milliliter
•Normal coagulation function, no evidences of hemorrhage
•Normal liver, heart, kidney function

Exclusion Criteria

•Pregnant or lactating females
•Proven active infectious diseases (e.g. viral hepatitis, TB)
•Not adequately controlled infections
•Known hypersensitivity to filgrastim or any other components of the study drug
•Unstable or uncontrolled cardiac disease or hypertension
•Currently participated in any other clinical trials
•Patients with previous or expected to receive systemic radiotherapy
•Evidence of metastatic disease in bone marrow, brain, et al
•Alcoholic or drug abusers
•Other conditions which in the opinion of the investigator preclude enrollment into the study