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Completed

NCT Number: NCT01238562

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

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).

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Key information

Conditions

Chemotherapy Patients

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YPEG-Filgrastim

Drug

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.

Primary outcomes

  1. Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study.

    Time frame: each cycle

Secondary outcomes

  1. Measurement of serum concentration of drugs for Pharmacokinetic study.

    Time frame: each cycle

Sponsors and collaborators

Lead sponsor

Xiamen Amoytop Biotech Co., Ltd.

Industry

Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Registry information

Official study title

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

Acronym: Filgrastim

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 10, 2010
Registry last updated
Feb 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.