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GCPGC in Chemotherapy-induced Neutropenia

Primary Purpose

Chemotherapy Induced Neutropenia

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GCPGC 3.6mg
GCPGC 6mg
Neulasta (pegfilgrastim) 6mg
GCPGC 6mg
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy Induced Neutropenia focused on measuring Pegfilgrastim, neutropenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chungbuk National University Hospital
  • National Cancer Center
  • Gachon University Gil Hospital
  • Seoul National University Bundang Hospital
  • Keimyung University Dongsan medical Center
  • Pusan National University Hospital
  • Chung-Ang University Hospital
  • Inha University Hospital
  • Konkuk University Medical Center
  • Kyung Hee University Medical Center
  • Seoul Asan Medical Center
  • Seoul National University Hospital
  • Seoul St.Mary's Hospital
  • SMG-SNU Boramae Medical Center
  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Stage I - Arm I: GCPGC I (3.6mg)

Stage I - Arm II: GCPGC II (6mg)

Stage II - Arm I: GCPGC

Stage II - Arm II: Neulasta

Arm Description

GCPGC 3.6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)

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

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.

Neulasta 6mg, sc, once at Day 3 per cycle (in patients receiving chemotherapy at Day 1)

Outcomes

Primary Outcome Measures

Duration of grade 4 neutropenia(ANC<500mm3) for 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 Outcome Measures

Time to ANC recovery (≥2,000/mm3) after nadir in cycle 1
Depth of ANC nadir in cycle 1
Rates of Febrile neutropenia in all cycles
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)
ANC values at Day 7 in all cycles (only for Stage II)
Rates of delay or dose-reduction of chemotherapy due to neutropenia (only for Stage II)
Number of hospitalization due to febrile neutropenia in cycle 2 and after (only for Stage II)
Number of intravenous antimicrobial treatments due to febrile neutropenia

Full Information

First Posted
February 6, 2011
Last Updated
November 5, 2013
Sponsor
Green Cross Corporation
Collaborators
Symyoo
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1. Study Identification

Unique Protocol Identification Number
NCT01328938
Brief Title
GCPGC in Chemotherapy-induced Neutropenia
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation
Collaborators
Symyoo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy Induced Neutropenia
Keywords
Pegfilgrastim, neutropenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stage I - Arm I: GCPGC I (3.6mg)
Arm Type
Experimental
Arm Description
GCPGC 3.6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)
Arm Title
Stage I - Arm II: GCPGC II (6mg)
Arm Type
Experimental
Arm Description
GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)
Arm Title
Stage II - Arm I: GCPGC
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage II - Arm II: Neulasta
Arm Type
Active Comparator
Arm Description
Neulasta 6mg, sc, once at Day 3 per cycle (in patients receiving chemotherapy at Day 1)
Intervention Type
Biological
Intervention Name(s)
GCPGC 3.6mg
Other Intervention Name(s)
Pegfilgrastim
Intervention Description
Stage I:Single blinded
Intervention Type
Biological
Intervention Name(s)
GCPGC 6mg
Other Intervention Name(s)
Pegfilgrastim
Intervention Description
Stage I: Single blinded;
Intervention Type
Biological
Intervention Name(s)
Neulasta (pegfilgrastim) 6mg
Intervention Description
Stage II: Active comparator, double blinded
Intervention Type
Biological
Intervention Name(s)
GCPGC 6mg
Other Intervention Name(s)
Pegfilgrastim
Intervention Description
Experimental: Stage II
Primary Outcome Measure Information:
Title
Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1
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.
Time Frame
in cycle 1
Secondary Outcome Measure Information:
Title
Time to ANC recovery (≥2,000/mm3) after nadir in cycle 1
Time Frame
in cycle 1
Title
Depth of ANC nadir in cycle 1
Time Frame
in cycle 1
Title
Rates of Febrile neutropenia in all cycles
Description
Stage I: only in cycle 1; Stage II: in all cycles
Time Frame
in all cycles
Title
Rates of severe neutropenia persisting more than 3 days in cycle 1 (only for Stage II)
Time Frame
in cycle 1
Title
ANC values at Day 7 in all cycles (only for Stage II)
Time Frame
Day 7 in alll cycles
Title
Rates of delay or dose-reduction of chemotherapy due to neutropenia (only for Stage II)
Time Frame
all cycles
Title
Number of hospitalization due to febrile neutropenia in cycle 2 and after (only for Stage II)
Time Frame
in clycle 2-6
Title
Number of intravenous antimicrobial treatments due to febrile neutropenia
Time Frame
in all cycles
Other Pre-specified Outcome Measures:
Title
Incidence of antibody development in patients receiving GCPGC compared to Neulasta
Time Frame
3 months after last treatment
Title
Vital sign, Physical examination, Laboratory tests, Occurrence of adverse reactions
Time Frame
in all cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Do-Youn Oh, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chang-Hee Lee, M.D., Ph.D.
Organizational Affiliation
Green Cross Corporation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seock-Ah Im, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungbuk National University Hospital
City
Chungju
State/Province
Chungchungbuk
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Ilsan
State/Province
KyungKi
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
State/Province
KyungKi
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Sungnam
State/Province
Kyungki
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul St.Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

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GCPGC in Chemotherapy-induced Neutropenia

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