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

NCT01238562 | Completed Phase 1 DMC

• 1 other identifier: TB1004CSF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chemotherapy Patients

Keywords

cancer patient; chemotherapy; carboplatin; taxol; cyclophosphamide; pharmorubicin

Outcome Measures

Primary Outcomes (1)

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

  each cycle

Secondary Outcomes (1)

• Measurement of serum concentration of drugs for Pharmacokinetic study.

  each cycle

Study Arms (5)

YPEG-Filgrastim, 10mcg/kg

EXPERIMENTAL

Drug: YPEG-Filgrastim

YPEG-Filgrastim, 20mcg/kg

EXPERIMENTAL

Drug: YPEG-Filgrastim

YPEG-Filgrastim, 30mcg/kg

EXPERIMENTAL

Drug: YPEG-Filgrastim

YPEG-Filgrastim, 45mcg/kg

EXPERIMENTAL

Drug: YPEG-Filgrastim

YPEG-Filgrastim, 60mcg/kg

EXPERIMENTAL

Drug: YPEG-Filgrastim

Interventions

YPEG-Filgrastim DRUG

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.

YPEG-Filgrastim, 10mcg/kg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiamen Amoytop Biotech Co., Ltd.: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Study Officials

• Shi Yuankai, Ph.D

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 10, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 4, 2013

Record last verified: 2010-03

Locations

CN (1)