Ignite Creation Date:
2024-05-06 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03381417
Status:
COMPLETED
Last Update Posted:
2018-01-02
First Post:
2017-12-11
Brief Title:
Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients
Sponsor:
Nanogen Pharmaceutical Biotechnology Joint Stock Company
Organization:
Nanogen Pharmaceutical Biotechnology Joint Stock Company
Study Overview
Official Title:
A Randomized Double-blind Parallel Study Comparing Efficacy and Safety of Pegcyte Nanogen and Reference Product Neulastim Roche for Prevention of Chemotherapy Accelerated AC RegimenInduced Neutropenia in Breast-cancer Patients
Status:
COMPLETED
Status Verified Date:
2017-12
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:
Accelerated AC regimen-Doxorubicin 60 mgm2Cyclophosphamide 600 mgm2 on day 1 day 14 of each cycle along with G-CSF support for up to 4 cycles followed by Paclitaxel 175 mgm2 in the next 4 cycles is the standard clinical practice in Vietnam for breast cancer this regimen is to facilitate the dose-dense schedule patients receive every-2-week therapy along with G-CSF support the accelerated dose-dense schedule improve disease-free and overall survival among women with breast cancer Primary objective of this study is to compare the efficacy and safety of Nanogens Pegcyte and Roches Neulastim for prevention of chemotherapy Accelerated AC regimen-induced neutropenia on breast cancer patients Breast cancer patients scheduled to receive myelosuppressive chemotherapy AC regimen will be recruited in this trial All eligible patients receive single subcutaneous injection of study drugs 24 hours after chemotherapy administration in each cycle for 3 consecutive cycles Efficacy and safety assessments will be assessed based on the incidence of severe neutropenia in combination of temperature 383 or sepsis or life threatening infection and incidence of serious adverse events
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None