GCPGC in Chemotherapy-induced Neutropenia

This study has been completed.
Sponsor:
Collaborator:
Symyoo
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01328938
First received: February 6, 2011
Last updated: November 5, 2013
Last verified: November 2013

February 6, 2011
November 5, 2013
October 2010
November 2012   (final data collection date for primary outcome measure)
Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1 [ Time Frame: in cycle 1 ] [ Designated as safety issue: No ]

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.

duration of grade 4 neutropenia(ANC<500mm3)for cycle 1. [ Time Frame: day1-21 in cycle 1 ] [ Designated as safety issue: Yes ]

Stage I ; The difference in mean duration of grade 4 neutropenia between GCPGC 3.6mg and GCPGC 6mg is measured by daily check(Day1-Day9) of 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 Filgrastim is measured by daily check of ANC(Day1-9) in cycle 1.

Complete list of historical versions of study NCT01328938 on ClinicalTrials.gov Archive Site
  • Time to ANC recovery (≥2,000/mm3) after nadir in cycle 1 [ Time Frame: in cycle 1 ] [ Designated as safety issue: No ]
  • Depth of ANC nadir in cycle 1 [ Time Frame: in cycle 1 ] [ Designated as safety issue: No ]
  • Rates of Febrile neutropenia in all cycles [ Time Frame: in all cycles ] [ Designated as safety issue: No ]
    Stage I: only in cycle 1; Stage II: in all cycles
  • Rates of severe neutropenia persisting more than 3 days in cycle 1 (only for Stage II) [ Time Frame: in cycle 1 ] [ Designated as safety issue: No ]
  • ANC values at Day 7 in all cycles (only for Stage II) [ Time Frame: Day 7 in alll cycles ] [ Designated as safety issue: No ]
  • Rates of delay or dose-reduction of chemotherapy due to neutropenia (only for Stage II) [ Time Frame: all cycles ] [ Designated as safety issue: No ]
  • Number of hospitalization due to febrile neutropenia in cycle 2 and after (only for Stage II) [ Time Frame: in clycle 2-6 ] [ Designated as safety issue: No ]
  • Number of intravenous antimicrobial treatments due to febrile neutropenia [ Time Frame: in all cycles ] [ Designated as safety issue: No ]
  • Rates of Febrile Neutropenia in all cycles [ Time Frame: day 1-21 in all cycles ] [ Designated as safety issue: Yes ]
  • Duration of severe neutropenia(ANC<500mm3),cycle 2-4 [ Time Frame: day 1-21, cycle 2-4 ] [ Designated as safety issue: Yes ]
  • Incidence of antibody development in patients receiving GCPGC compared to Neulasta [ Time Frame: 3 months after last treatment ] [ Designated as safety issue: Yes ]
  • Vital sign, Physical examination, Laboratory tests, Occurrence of adverse reactions [ Time Frame: in all cycles ] [ Designated as safety issue: Yes ]
Not Provided
 
GCPGC in Chemotherapy-induced Neutropenia
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)

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Chemotherapy Induced Neutropenia
  • Biological: GCPGC 3.6mg
    Stage I:Single blinded
    Other Name: Pegfilgrastim
  • Biological: GCPGC 6mg
    Stage I: Single blinded;
    Other Name: Pegfilgrastim
  • Biological: Neulasta (pegfilgrastim) 6mg
    Stage II: Active comparator, double blinded
  • Biological: GCPGC 6mg
    Experimental: Stage II
    Other Name: Pegfilgrastim
  • Experimental: Stage I - Arm I: GCPGC I (3.6mg)
    GCPGC 3.6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)
    Intervention: Biological: GCPGC 3.6mg
  • Experimental: Stage I - Arm II: GCPGC II (6mg)
    GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)
    Intervention: Biological: GCPGC 6mg
  • Experimental: Stage II - Arm I: GCPGC

    GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1).

    The recommended dose in Stage II was determinated as GCPGC 6mg in Stage I.

    Intervention: Biological: GCPGC 6mg
  • Active Comparator: Stage II - Arm II: Neulasta
    Neulasta 6mg, sc, once at Day 3 per cycle (in patients receiving chemotherapy at Day 1)
    Intervention: Biological: Neulasta (pegfilgrastim) 6mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
177
May 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01328938
GCPGC P2/3
No
Green Cross Corporation
Green Cross Corporation
Symyoo
Principal Investigator: Do-Youn Oh, M.D., Ph.D. Seoul National University Hospital
Study Director: Chang-Hee Lee, M.D., Ph.D. Green Cross Corporation
Principal Investigator: Seock-Ah Im, M.D., Ph.D. Seoul National University Hospital
Green Cross Corporation
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP