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Safety,Tolerability,Pharmacokinetics and Pharmacodynamics Phase 1 Study of Pegfilgrastim in Chemotherapy Patients

Phase 1
18 Years
70 Years
Open (Enrolling)

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Trial Information

Safety,Tolerability,Pharmacokinetics and Pharmacodynamics Phase 1 Study of Pegfilgrastim in Chemotherapy Patients

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

- Known hypersensitivity to filgrastim or any of the products to be administered during

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Blood concentration of pegfilgrastim for pharmacokinetics

Outcome Time Frame:

42 days

Safety Issue:


Principal Investigator

Shi Yuankai, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute and Hospital, CAMS


China: Food and Drug Administration

Study ID:




Start Date:

February 2012

Completion Date:

June 2013

Related Keywords:

  • Neutropenia
  • Pegylation
  • G-CSF
  • Pharmacokinetics
  • Pharmacodynamics
  • Neutropenia