Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01238562

Acronym

Filgrastim

Enrollment

Registered

2010-11-10

Start date

2010-04-30

Completion date

2011-11-30

Last updated

2013-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy Patients

Keywords

cancer patient, chemotherapy, carboplatin, taxol, cyclophosphamide, pharmorubicin

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).

Interventions

DRUGYPEG-Filgrastim

s.c, single dose of 10mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study.	each cycle

Secondary

Measure	Time frame
Measurement of serum concentration of drugs for Pharmacokinetic study.	each cycle

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026