Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients
NCT ID: NCT01238562
Last Updated: 2013-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2010-04-30
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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YPEG-Filgrastim, 10mcg/kg
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.
YPEG-Filgrastim, 20mcg/kg
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.
YPEG-Filgrastim, 30mcg/kg
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.
YPEG-Filgrastim, 45mcg/kg
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
YPEG-Filgrastim, 60mcg/kg
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.
Interventions
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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.
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.
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.
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Xiamen Amoytop Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Shi Yuankai, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Other Identifiers
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TB1004CSF
Identifier Type: -
Identifier Source: org_study_id
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