Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients

This study has been completed.
Sponsor:
Collaborator:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01238562
First received: November 5, 2010
Last updated: January 31, 2013
Last verified: March 2010
  Purpose

This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish dose-response relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER).


Condition Intervention Phase
Chemotherapy Patients
Drug: YPEG-Filgrastim
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Xiamen Amoytop Biotech Co., Ltd.:

Primary Outcome Measures:
  • Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study. [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measurement of serum concentration of drugs for Pharmacokinetic study. [ Time Frame: each cycle ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YPEG-Filgrastim, 10mcg/kg Drug: YPEG-Filgrastim
s.c, single dose of 10mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.
Experimental: YPEG-Filgrastim, 20mcg/kg Drug: YPEG-Filgrastim
s.c, single dose of 20mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.
Experimental: YPEG-Filgrastim, 30mcg/kg Drug: YPEG-Filgrastim
s.c, single dose of 30mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.
Experimental: YPEG-Filgrastim, 45mcg/kg Drug: YPEG-Filgrastim
s.c, single dose of 45mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir
Experimental: YPEG-Filgrastim, 60mcg/kg Drug: YPEG-Filgrastim
s.c, single dose of 60mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238562

Locations
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Sponsors and Collaborators
Xiamen Amoytop Biotech Co., Ltd.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Shi Yuankai, Ph.D Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01238562     History of Changes
Other Study ID Numbers: TB1004CSF
Study First Received: November 5, 2010
Last Updated: January 31, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Xiamen Amoytop Biotech Co., Ltd.:
cancer patient
chemotherapy
carboplatin
taxol
cyclophosphamide
pharmorubicin

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014