Ignite Creation Date:
2024-05-06 @ 12:43 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01648322
Status:
COMPLETED
Last Update Posted:
2018-10-03
First Post:
2012-04-27
Brief Title:
Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Sponsor:
EVIVE Biotechnology
Organization:
EVIVE Biotechnology
Study Overview
Official Title:
A Phase II Randomized Multi-Centre Open-Label Active-Controlled Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Status:
COMPLETED
Status Verified Date:
2018-10
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 open label dose finding study to evaluate the efficacy and safety of F-627 on women with Stage I-IV breast cancer receiving chemotherapy treatment
Detailed Description:
This is a randomized multi-center dose finding open label positive controlled Phase II study of the efficacy and safety of once-per-cycle of F-627 compared with Neulasta pegfilgrastim in women with breast cancer who are receiving myelotoxic chemotherapy TC docetaxel cyclophosphamide or TAC docetaxel doxorubicin cyclophosphamide
The primary objective of this study is to evaluate the efficacy and safety of various single cycle doses of F-627 as compared with the standard dosing of Neulasta pegfilgrastim in breast cancer patients experiencing myelotoxic chemotherapy Myelotoxicity in this study will be defined by the duration of moderate neutropenia the number of days in which the patient has had an absolute neutrophil count ANC 10 109L during the first cycle of their chemotherapy treatment each chemotherapy cycle is expected to last 21 days This by definition includes grade 3 moderate and grade 4 severe neutropenia Doses of F-627 to be tested for subjects receiving TC chemotherapy are 80 µgkgdose 240 µgkgdose and 320 µgkgdose For subjects receiving TAC chemotherapy only 240 µgkgdose and 320 µgkgdose are to be tested
The primary objective of this study is to evaluate the efficacy and safety of various single cycle doses of F-627 as compared with the standard dosing of Neulasta pegfilgrastim in breast cancer patients experiencing myelotoxic chemotherapy Myelotoxicity in this study will be defined by the duration of moderate neutropenia the number of days in which the patient has had an absolute neutrophil count ANC 10 109L during the first cycle of their chemotherapy treatment each chemotherapy cycle is expected to last 21 days This by definition includes grade 3 moderate and grade 4 severe neutropenia Doses of F-627 to be tested for subjects receiving TC chemotherapy are 80 µgkgdose 240 µgkgdose and 320 µgkgdose For subjects receiving TAC chemotherapy only 240 µgkgdose and 320 µgkgdose are to be tested
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