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| Name | Class |
|---|---|
| Symyoo | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage I - Arm I: GCPGC I (3.6mg) | Experimental | GCPGC 3.6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1) |
|
| Stage I - Arm II: GCPGC II (6mg) | Experimental | GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1) |
|
| Stage II - Arm I: GCPGC | Experimental | 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. |
|
| Stage II - Arm II: Neulasta | Active Comparator | Neulasta 6mg, sc, once at Day 3 per cycle (in patients receiving chemotherapy at Day 1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GCPGC 3.6mg | Biological | Stage I:Single blinded |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Do-Youn Oh, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Chang-Hee Lee, M.D., Ph.D. | Green Cross Corporation | Study Director |
| Seock-Ah Im, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Chungju | Chungchungbuk | South Korea | |||
| National Cancer Center |
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| GCPGC 6mg | Biological | Stage I: Single blinded; |
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| Neulasta (pegfilgrastim) 6mg | Biological | Stage II: Active comparator, double blinded |
|
| GCPGC 6mg | Biological | Experimental: Stage II |
|
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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) | in cycle 1 |
| ANC values at Day 7 in all cycles (only for Stage II) | Day 7 in alll cycles |
| Rates of delay or dose-reduction of chemotherapy due to neutropenia (only for Stage II) | all cycles |
| Number of hospitalization due to febrile neutropenia in cycle 2 and after (only for Stage II) | in clycle 2-6 |
| Number of intravenous antimicrobial treatments due to febrile neutropenia | in all cycles |
| 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 |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
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| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
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