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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Chemotherapy Patients

Intervention / Treatment
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* Drug: YPEG-Filgrastim
* Drug: YPEG-Filgrastim
* Drug: YPEG-Filgrastim
* Drug: YPEG-Filgrastim
* Drug: YPEG-Filgrastim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YPEG-Filgrastim, 10mcg/kg<br> | Drug: YPEG-Filgrastim<br>* 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.<br>|
| Experimental: YPEG-Filgrastim, 20mcg/kg<br> | Drug: YPEG-Filgrastim<br>* 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.<br>|
| Experimental: YPEG-Filgrastim, 30mcg/kg<br> | Drug: YPEG-Filgrastim<br>* 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.<br>|
| Experimental: YPEG-Filgrastim, 45mcg/kg<br> | Drug: YPEG-Filgrastim<br>* 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<br>|
| Experimental: YPEG-Filgrastim, 60mcg/kg<br> | Drug: YPEG-Filgrastim<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study. |  | each cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of serum concentration of drugs for Pharmacokinetic study. |  | each cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer patient, chemotherapy, carboplatin, taxol, cyclophosphamide, pharmorubicin