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NCT Number: NCT01328938

GCPGC in Chemotherapy-induced Neutropenia

This study is adaptive design and it consists of stage I and stage II.

Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC in chemotherapy-induced neutropenia. 2 Different doses of GCPGC will be investigated in a total of 60 Breast cancer patients who are receiving chemotherapy.

Stage II is multi-center, parallel-group, double-blind,phase III study to evaluate the efficacy and safety of once per cycle GCPGC in chemotherapy-induced neutropenia compared to Neulasta (pegfilgrastim). A total of 120 patients receiving chemotherapy will participate into this phase.

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Key information

Conditions

Chemotherapy Induced Neutropenia Agranulocytosis Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chungbuk National University Hospital, Chungju, Chungchungbuk, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GCPGC 3.6mg

Biological

Stage I:Single blinded

Other names: Pegfilgrastim

GCPGC 6mg

Biological

Stage I: Single blinded;

Other names: Pegfilgrastim

Neulasta (pegfilgrastim) 6mg

Biological

Stage II: Active comparator, double blinded

Primary outcomes

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

    Time frame: in cycle 1

    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.

Secondary outcomes

  1. Time to ANC recovery (≥2,000/mm3) after nadir in cycle 1

    Time frame: in cycle 1

  2. Depth of ANC nadir in cycle 1

    Time frame: in cycle 1

  3. Rates of Febrile neutropenia in all cycles

    Time frame: in all cycles

    Stage I: only in cycle 1; Stage II: in all cycles

  4. Rates of severe neutropenia persisting more than 3 days in cycle 1 (only for Stage II)

    Time frame: in cycle 1

  5. ANC values at Day 7 in all cycles (only for Stage II)

    Time frame: Day 7 in alll cycles

  6. Rates of delay or dose-reduction of chemotherapy due to neutropenia (only for Stage II)

    Time frame: all cycles

  7. Number of hospitalization due to febrile neutropenia in cycle 2 and after (only for Stage II)

    Time frame: in clycle 2-6

  8. Number of intravenous antimicrobial treatments due to febrile neutropenia

    Time frame: in all cycles

Other outcomes

  1. Incidence of antibody development in patients receiving GCPGC compared to Neulasta

    Time frame: 3 months after last treatment

  2. Vital sign, Physical examination, Laboratory tests, Occurrence of adverse reactions

    Time frame: in all cycles

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Collaborators

  • Symyoo

Registry information

Official study title

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)

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Apr 5, 2011
Registry last updated
Nov 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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