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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


Phase 1
18 Years
70 Years
Not Enrolling
Both
Chemotherapy Patients

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Outcome Measure:

Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study.

Outcome Time Frame:

each cycle

Safety Issue:

Yes

Principal Investigator

Shi Yuankai, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute and Hospital, CAMS

Authority:

China: Food and Drug Administration

Study ID:

TB1004CSF

NCT ID:

NCT01238562

Start Date:

April 2010

Completion Date:

November 2011

Related Keywords:

  • Chemotherapy Patients
  • cancer patient
  • chemotherapy
  • carboplatin
  • taxol
  • cyclophosphamide
  • pharmorubicin

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