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

This study has been completed.
Sponsor:
Collaborator:
Cancer Institute and Hospital, CAMS
Information provided by (Responsible Party):
Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01238562
First received: November 5, 2010
Last updated: January 31, 2013
Last verified: March 2010
History of Changes

November 5, 2010
January 31, 2013
April 2010
November 2011   (final data collection date for primary outcome measure)
Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study. [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01238562 on ClinicalTrials.gov Archive Site
Measurement of serum concentration of drugs for Pharmacokinetic study. [ Time Frame: each cycle ] [ Designated as safety issue: No ]
Measurement of serum concentration for Pharmacokinetic study. [ Time Frame: each cycle ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Chemotherapy Patients
  • Drug: YPEG-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.
  • Drug: YPEG-Filgrastim
    s.c, single dose of 20mcg/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.
  • Drug: YPEG-Filgrastim
    s.c, single dose of 30mcg/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.
  • Drug: YPEG-Filgrastim
    s.c, single dose of 45mcg/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
  • Drug: YPEG-Filgrastim
    s.c, single dose of 60mcg/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.
  • Experimental: YPEG-Filgrastim, 10mcg/kg
    Intervention: Drug: YPEG-Filgrastim
  • Experimental: YPEG-Filgrastim, 20mcg/kg
    Intervention: Drug: YPEG-Filgrastim
  • Experimental: YPEG-Filgrastim, 30mcg/kg
    Intervention: Drug: YPEG-Filgrastim
  • Experimental: YPEG-Filgrastim, 45mcg/kg
    Intervention: Drug: YPEG-Filgrastim
  • Experimental: YPEG-Filgrastim, 60mcg/kg
    Intervention: Drug: YPEG-Filgrastim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01238562
TB1004CSF
Yes
Xiamen Amoytop Biotech Co., Ltd.
Xiamen Amoytop Biotech Co., Ltd.
Cancer Institute and Hospital, CAMS
Principal Investigator: Shi Yuankai, Ph.D Cancer Institute and Hospital, CAMS
Xiamen Amoytop Biotech Co., Ltd.
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP