Ignite Creation Date:
2024-05-05 @ 11:26 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01328938
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2011-02-06
Brief Title:
GCPGC in Chemotherapy-induced Neutropenia
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
A RandomizedMulti-centerParallel-group Phase IISingle-blindPhase IIIDouble- BlindStudy to Determine the Optimal Dose and to Evaluate the Efficacy and Safety of GCPGC on Chemotherapy-induced Neutropenia Compared to NeulastaPegfilgrastim
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-blindphase 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
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-blindphase 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None