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)
1 other identifier
interventional
177
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2010
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 6, 2011
CompletedFirst Posted
Study publicly available on registry
April 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedNovember 6, 2013
November 1, 2013
2.1 years
February 6, 2011
November 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
in cycle 1
Secondary Outcomes (8)
Time to ANC recovery (≥2,000/mm3) after nadir in cycle 1
in cycle 1
Depth of ANC nadir in cycle 1
in cycle 1
Rates of Febrile neutropenia in all cycles
in all cycles
Rates of severe neutropenia persisting more than 3 days in cycle 1 (only for Stage II)
in cycle 1
ANC values at Day 7 in all cycles (only for Stage II)
Day 7 in alll cycles
- +3 more secondary outcomes
Other Outcomes (2)
Incidence of antibody development in patients receiving GCPGC compared to Neulasta
3 months after last treatment
Vital sign, Physical examination, Laboratory tests, Occurrence of adverse reactions
in all cycles
Study Arms (4)
Stage I - Arm I: GCPGC I (3.6mg)
EXPERIMENTALGCPGC 3.6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)
Stage I - Arm II: GCPGC II (6mg)
EXPERIMENTALGCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)
Stage II - Arm I: GCPGC
EXPERIMENTALGCPGC 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.
Stage II - Arm II: Neulasta
ACTIVE COMPARATORNeulasta 6mg, sc, once at Day 3 per cycle (in patients receiving chemotherapy at Day 1)
Interventions
Stage I:Single blinded
Stage I: Single blinded;
Stage II: Active comparator, double blinded
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Green Cross Corporationlead
- Symyoocollaborator
Study Sites (15)
Chungbuk National University Hospital
Chungju, Chungchungbuk, South Korea
National Cancer Center
Ilsan, KyungKi, South Korea
Gachon University Gil Hospital
Incheon, KyungKi, South Korea
Seoul National University Bundang Hospital
Sungnam, Kyungki, South Korea
Keimyung University Dongsan medical Center
Daegu, South Korea
Pusan National University Hospital
Pusan, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Inha University Hospital
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
Kyung Hee University Medical Center
Seoul, South Korea
Seoul Asan Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Seoul St.Mary's Hospital
Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2011
First Posted
April 5, 2011
Study Start
October 1, 2010
Primary Completion
November 1, 2012
Study Completion
May 1, 2013
Last Updated
November 6, 2013
Record last verified: 2013-11