GCPGC in Chemotherapy-induced Neutropenia

November 5, 2013 updated by: Green Cross Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Pusan, Korea, Republic of
        • Pusan National University Hospital
      • Seoul, Korea, Republic of
        • Seoul National 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
        • SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republic of
        • Seoul Asan Medical Center
      • Seoul, Korea, Republic of
        • Seoul St.Mary's Hospital
      • Seoul, Korea, Republic of
        • Inha University Hospital
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital
    • Chungchungbuk
      • Chungju, Chungchungbuk, Korea, Republic of
        • Chungbuk National University Hospital
    • KyungKi
      • Ilsan, KyungKi, Korea, Republic of
        • National Cancer Center
      • Incheon, KyungKi, Korea, Republic of
        • Gachon University Gil Hospital
    • Kyungki
      • Sungnam, Kyungki, Korea, Republic of
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Pegfilgrastim
Biological: GCPGC 6mg
Experimental: Stage II
Other Names:
  • 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
Stage I: Single blinded;
Other Names:
  • Pegfilgrastim
Biological: GCPGC 6mg
Experimental: Stage II
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
in cycle 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to ANC recovery (≥2,000/mm3) after nadir in cycle 1
Time Frame: in cycle 1
in cycle 1
Depth of ANC nadir in cycle 1
Time Frame: in cycle 1
in cycle 1
Rates of Febrile neutropenia in all cycles
Time Frame: in all cycles
Stage I: only in cycle 1; Stage II: in all cycles
in all cycles
Rates of severe neutropenia persisting more than 3 days in cycle 1 (only for Stage II)
Time Frame: in cycle 1
in cycle 1
ANC values at Day 7 in all cycles (only for Stage II)
Time Frame: Day 7 in alll cycles
Day 7 in alll cycles
Rates of delay or dose-reduction of chemotherapy due to neutropenia (only for Stage II)
Time Frame: all cycles
all cycles
Number of hospitalization due to febrile neutropenia in cycle 2 and after (only for Stage II)
Time Frame: in clycle 2-6
in clycle 2-6
Number of intravenous antimicrobial treatments due to febrile neutropenia
Time Frame: in all cycles
in all cycles

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of antibody development in patients receiving GCPGC compared to Neulasta
Time Frame: 3 months after last treatment
3 months after last treatment
Vital sign, Physical examination, Laboratory tests, Occurrence of adverse reactions
Time Frame: in all cycles
in all cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Cross Corporation

Collaborators

Symyoo

Investigators

  • Principal Investigator: Seock-Ah Im, M.D., Ph.D., Seoul National University Hospital
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

February 6, 2011

First Submitted That Met QC Criteria

April 4, 2011

First Posted (Estimate)

April 5, 2011

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCPGC P2/3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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