Ignite Creation Date:
2024-05-06 @ 9:01 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02872103
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2016-08-08
Brief Title:
Placebo-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 Double-Blind Placebo 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 double-blind and placebo controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with stage II-IV breast cancer receiving chemotherapy treatment
Detailed Description:
This is a randomized multi-center single dose double-blind placebo controlled phase III study of the efficacy and safety of once-per-cycle of F-627 in women with stage II-IV breast cancer who are receiving myelotoxic TA chemotherapy treatment Taxotere docetaxel Adriamycindoxorubicin F-627 is designed to treat neutropenia an abnormally low number of neutrophils a type of white blood cell in the blood Neutropenia is often seen in cancer patients receiving myelotoxic chemotherapy
The primary objective of this study is to evaluate the efficacy and safety of single fixed dose of F-627 in breast cancer patients experiencing myelotoxic chemotherapy in comparison to placebo F-627 or placebo is to be administered subcutaneously 24 hours after chemotherapy in each 21-day cycle of chemotherapy treatment up to 4 cycles Patients randomized to placebo arm will receive F-627 except in cycle 1 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
The primary objective of this study is to evaluate the efficacy and safety of single fixed dose of F-627 in breast cancer patients experiencing myelotoxic chemotherapy in comparison to placebo F-627 or placebo is to be administered subcutaneously 24 hours after chemotherapy in each 21-day cycle of chemotherapy treatment up to 4 cycles Patients randomized to placebo arm will receive F-627 except in cycle 1 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
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