NCT01637493
Unknown
Phase 1
Safety,Tolerability,Pharmacokinetics and Pharmacodynamics Phase 1 Study of Pegfilgrastim in Chemotherapy Patients
Overview
- Phase
- Phase 1
- Intervention
- Pegfilgrastim
- Conditions
- Neutropenia
- Sponsor
- Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Blood concentration of pegfilgrastim for pharmacokinetics
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to examine the safety,tolerability,pharmacokinetics and pharmacodynamics of Pegfilgrastim in patients with chemotherapy-induced neutropenia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: 18～70 years
- •Confirmed malignant tumor patients by histopathological or cytological diagnosis, not previously treated with chemotherapy or radiotherapy,suitable for chemotherapy with carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin
- •Karnofsky score ≥ 70
- •Normal coagulation function, no evidences of hemorrhage,WBC ≥ 3,500 per cubic milliliter, ANC ≥ 1,500 per cubic milliliter, PLT ≥ 100,000 per cubic milliliter
- •Normal liver, heart, kidney function
- •Life expectancy \> 3 months
- •Signed informed consent
Exclusion Criteria
- •Not adequately controlled infections(e.g. ANC ≥ 12,000 per cubic milliliter,temperature \> 38.2℃)
- •Evidence of metastatic disease in bone marrow,or with other malignant tumors
- •Subjects with symptomatic brain metastases
- •Pregnant or breast-feeding or in menstrual period females
- •Participated more than 3 clinical trials in nearly a year(as subjects)
- •Currently participated in any other clinical trials,or Used any prescription medication could impact on the metabolism of investigational drug, or participated in any other clinical trial within one month from the date of the screening visit
- •Donation of whole blood or a unit of blood within three months prior to the start of study
- •Known hypersensitivity to filgrastim or any of the products to be administered during dosing
- •Evidence of, or treatment for, drug or alcohol abuse within one year from date of screening visit
- •Other conditions which in the opinion of the investigator preclude enrollment into the study
Arms & Interventions
Pegfilgrastim, 30mcg/kg
Intervention: Pegfilgrastim
Pegfilgrastim, 60mcg/kg
Intervention: Pegfilgrastim
Pegfilgrastim, 100mcg/kg
Intervention: Pegfilgrastim
Pegfilgrastim, 200mcg/kg
Intervention: Pegfilgrastim
Outcomes
Primary Outcomes
Blood concentration of pegfilgrastim for pharmacokinetics
Time Frame: 42 days
Secondary Outcomes
- Pharmacokinetics: AUC(0-t),Cmax, Tmax, half-life,Cl(42 days)
- Absolute Neutrophil Count (ANC)(63 days)
- CD34+ Cell count(63 days)
- Safety data: including physical examinations ( include injection site reactions) , laboratory evaluations( ECGs, AST, ALT, Cr, BUN, hemostasis and coagulation test, electrolyte test ), vital signs assessments, and adverse effects (AEs).(63days)
- samples for immunogenicity(days 21,42,63)
Study Sites (1)
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