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

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ClinicalTrials.gov Identifier: NCT01238562
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : February 4, 2013
Sponsor:
Collaborator:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Xiamen Amoytop Biotech Co., Ltd.

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).

Condition or disease Intervention/treatment Phase
Chemotherapy Patients Drug: YPEG-Filgrastim Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official 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
Study Start Date : April 2010
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: YPEG-Filgrastim, 10mcg/kg 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.
Experimental: YPEG-Filgrastim, 20mcg/kg 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.
Experimental: YPEG-Filgrastim, 30mcg/kg 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.
Experimental: YPEG-Filgrastim, 45mcg/kg 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
Experimental: YPEG-Filgrastim, 60mcg/kg 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.



Primary Outcome Measures :
  1. Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study. [ Time Frame: each cycle ]

Secondary Outcome Measures :
  1. Measurement of serum concentration of drugs for Pharmacokinetic study. [ Time Frame: each cycle ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238562


Locations
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Sponsors and Collaborators
Xiamen Amoytop Biotech Co., Ltd.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Shi Yuankai, Ph.D Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Responsible Party: Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01238562     History of Changes
Other Study ID Numbers: TB1004CSF
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: March 2010

Keywords provided by Xiamen Amoytop Biotech Co., Ltd.:
cancer patient
chemotherapy
carboplatin
taxol
cyclophosphamide
pharmorubicin

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs