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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)
Both
Neutropenia

Thank you

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
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

Type of Study:

Interventional

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:

No

Principal Investigator

Shi Yuankai, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute and Hospital, CAMS

Authority:

China: Food and Drug Administration

Study ID:

JY062011A

NCT ID:

NCT01637493

Start Date:

February 2012

Completion Date:

June 2013

Related Keywords:

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

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