Ignite Creation Date:
2024-05-06 @ 10:26 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03252431
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2017-08-14
Brief Title:
Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Sponsor:
EVIVE Biotechnology
Organization:
EVIVE Biotechnology
Study Overview
Official Title:
A Phase III Randomized Multi-Centre Open-Label Fixed Dose Neulasta Active-Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Status:
COMPLETED
Status Verified Date:
2021-04
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 is a randomized multi-center single dose open-label and Neulasta controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with Stage I - III invasive breast cancer receiving chemotherapy treatment
Detailed Description:
This is a Phase III global two arm open label clinical study will randomize approximately 400 female subjects approximately 200 per arm with Stage I - III invasive breast cancer who are to receive neoadjuvant or adjuvant myelotoxic TC chemotherapy treatment docetaxel cyclophosphamide 75 and 600 mgm2 respectively Subjects in this study will be those who are scheduled to undergo at least four 21-day cycles of chemotherapy treatment Subjects may be scheduled for more than 4 cycles of chemotherapy however study participation will be limited to a subjects first 4 cycles
The primary objective of this study will be to evaluate the efficacy of F-627 given as a single fixed dose 20 mg pre-filled syringe as compared to Neulasta standard dosing 6 mg in the first chemotherapy cycle The primary endpoint will be the duration of grade 4 severe neutropenia - the number of days in which the patient has had an absolute neutrophil count ANC 05 x 109L observed in chemotherapy cycle 1
Approximately 24 hours after chemotherapy completion in each cycle Day 2 of the cycle subjects will receive one of the following treatments
Arm 1 F-627 20 mg fixed dose pre-filled syringe administered on Day 2 of each of 4 chemotherapy cycles
Arm 2 6 mg fixed dose Neulasta administered on Day 2 of each of 4 chemotherapy cycles Randomization will occur in an equal ratio 11 using a central randomization system IWRS on Day 1 of the study the day of chemotherapy administration for the first chemotherapy cycle
This study is open-label however study drug injections are to be administered separately by qualified study personnel to allow study investigators to remain blinded and perform study assessments without knowledge of treatment assignment
The primary objective of this study will be to evaluate the efficacy of F-627 given as a single fixed dose 20 mg pre-filled syringe as compared to Neulasta standard dosing 6 mg in the first chemotherapy cycle The primary endpoint will be the duration of grade 4 severe neutropenia - the number of days in which the patient has had an absolute neutrophil count ANC 05 x 109L observed in chemotherapy cycle 1
Approximately 24 hours after chemotherapy completion in each cycle Day 2 of the cycle subjects will receive one of the following treatments
Arm 1 F-627 20 mg fixed dose pre-filled syringe administered on Day 2 of each of 4 chemotherapy cycles
Arm 2 6 mg fixed dose Neulasta administered on Day 2 of each of 4 chemotherapy cycles Randomization will occur in an equal ratio 11 using a central randomization system IWRS on Day 1 of the study the day of chemotherapy administration for the first chemotherapy cycle
This study is open-label however study drug injections are to be administered separately by qualified study personnel to allow study investigators to remain blinded and perform study assessments without knowledge of treatment assignment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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