Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients

Hangzhou Jiuyuan Gene Engineering

Status and phase: Unknown; Phase 1

Conditions: Neutropenia

Treatments: Drug: Pegfilgrastim

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01637493

JY062011A

Details and patient eligibility

About

The purpose of this study is to examine the safety,tolerability,pharmacokinetics and pharmacodynamics of Pegfilgrastim in patients with chemotherapy-induced neutropenia.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Pegfilgrastim, 30mcg/kg

Experimental group

Treatment:

Drug: Pegfilgrastim

Drug: Pegfilgrastim

Drug: Pegfilgrastim

Drug: Pegfilgrastim

Pegfilgrastim, 60mcg/kg

Experimental group

Treatment:

Drug: Pegfilgrastim

Drug: Pegfilgrastim

Drug: Pegfilgrastim

Drug: Pegfilgrastim

Pegfilgrastim, 100mcg/kg

Experimental group

Treatment:

Drug: Pegfilgrastim

Drug: Pegfilgrastim

Drug: Pegfilgrastim

Drug: Pegfilgrastim

Pegfilgrastim, 200mcg/kg

Experimental group

Treatment:

Drug: Pegfilgrastim

Drug: Pegfilgrastim

Drug: Pegfilgrastim

Drug: Pegfilgrastim