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A Randomized,Multi-center,Parallel-group, Phase II(Single-blind)/Phase III(Double- Blind)Study to Determine the Optimal Dose and to Evaluate the Efficacy and Safety of GCPGC on Chemotherapy-induced Neutropenia Compared to Neulasta(Pegfilgrastim)


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Female
Chemotherapy Induced Neutropenia

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Trial Information

A Randomized,Multi-center,Parallel-group, Phase II(Single-blind)/Phase III(Double- Blind)Study to Determine the Optimal Dose and to Evaluate the Efficacy and Safety of GCPGC on Chemotherapy-induced Neutropenia Compared to Neulasta(Pegfilgrastim)


GCPGC ia a solution for containing pegfilgrastim. Pegfilgrastim is a covalent conjugate of
recombinant human granulocyte colony-stimulating factor (G-CSF) with a polyethylene glycol
(PEG) which has long half life compared to filgrastim, resulting in dosing advantage.


Inclusion Criteria:



- women(≥ 18 years old) diagnosed with breast cancer who are receiving chemotherapy
inducing neutropenia

- body weight of 45kg and more

- ECOG performance status 2 and less

- ANC ≥1,500mm3 and Platelet ≥100,000/mm3

- life expectancy of 3 months and more

- given written informed consent

Exclusion Criteria:

- had previous exposure to pegfilgrastim or filgrastim

- had received systemic antibiotics within 72hrs of chemotherapy

- prior total cumulative lifetime exposure to doxorubicin more than 240 mg/m or
epirubicin more than 600 mg/m

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1

Outcome Description:

Stage I: The difference in mean duration of grade 4 neutropenia between GCPGC 3.6mg and GCPGC 6mg is measured by check ANC in cycle I. Stage II : The difference in mean duration of grade 4 neutropenia between GCPGC which dose was determined at Stage I and Neulasta is measured by check ANC in cycle 1.

Outcome Time Frame:

in cycle 1

Safety Issue:

No

Principal Investigator

Do-Youn Oh, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

GCPGC P2/3

NCT ID:

NCT01328938

Start Date:

October 2010

Completion Date:

June 2013

Related Keywords:

  • Chemotherapy Induced Neutropenia
  • Pegfilgrastim
  • neutropenia
  • Neutropenia

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