Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
177 participants
INTERVENTIONAL
2010-10-31
2013-05-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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)
GCPGC 3.6mg
Stage I:Single blinded
Stage I - Arm II: GCPGC II (6mg)
GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)
GCPGC 6mg
Stage I: Single blinded;
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.
GCPGC 6mg
Experimental: Stage II
Stage II - Arm II: Neulasta
Neulasta 6mg, sc, once at Day 3 per cycle (in patients receiving chemotherapy at Day 1)
Neulasta (pegfilgrastim) 6mg
Stage II: Active comparator, double blinded
Interventions
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GCPGC 3.6mg
Stage I:Single blinded
GCPGC 6mg
Stage I: Single blinded;
Neulasta (pegfilgrastim) 6mg
Stage II: Active comparator, double blinded
GCPGC 6mg
Experimental: Stage II
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Symyoo
INDUSTRY
Green Cross Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Do-Youn Oh, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Chang-Hee Lee, M.D., Ph.D.
Role: STUDY_DIRECTOR
Green Cross Corporation
Seock-Ah Im, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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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
Countries
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Other Identifiers
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GCPGC P2/3
Identifier Type: -
Identifier Source: org_study_id