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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
  Purpose

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.


Condition Intervention Phase
Chemotherapy Induced Neutropenia
Biological: GCPGC 3.6mg
Biological: GCPGC 6mg
Biological: Neulasta (pegfilgrastim) 6mg
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Enrollment: 177
Study Start Date: October 2010
Study Completion Date: May 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Biological: GCPGC 3.6mg
Stage I:Single blinded
Other Name: Pegfilgrastim
Experimental: Stage I - Arm II: GCPGC II (6mg)
GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)
Biological: GCPGC 6mg
Stage I: Single blinded;
Other Name: Pegfilgrastim
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.

Biological: GCPGC 6mg
Experimental: Stage II
Other Name: Pegfilgrastim
Active Comparator: Stage II - Arm II: Neulasta
Neulasta 6mg, sc, once at Day 3 per cycle (in patients receiving chemotherapy at Day 1)
Biological: Neulasta (pegfilgrastim) 6mg
Stage II: Active comparator, double blinded

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01328938

Locations
Korea, Republic of
Chungbuk National University Hospital
Chungju, Chungchungbuk, Korea, Republic of
National Cancer Center
Ilsan, KyungKi, Korea, Republic of
Gachon University Gil Hospital
Incheon, KyungKi, Korea, Republic of
Seoul National University Bundang Hospital
Sungnam, Kyungki, Korea, Republic of
Keimyung University Dongsan medical Center
Daegu, Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of
Inha University Hospital
Seoul, Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of
Kyung Hee University Medical Center
Seoul, Korea, Republic of
Chung-Ang University Hospital
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Seoul St.Mary's Hospital
Seoul, Korea, Republic of
Seoul Asan Medical Center
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Green Cross Corporation
Symyoo
Investigators
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
  More Information

No publications provided

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01328938     History of Changes
Other Study ID Numbers: GCPGC P2/3
Study First Received: February 6, 2011
Last Updated: November 5, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Green Cross Corporation:
Pegfilgrastim
neutropenia

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Hematologic Diseases
Leukocyte Disorders
Leukopenia

ClinicalTrials.gov processed this record on November 24, 2014