Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT02391194
Status:
COMPLETED
Last Update Posted:
2017-03-22
First Post:
2015-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
Sponsor:
Avelas Biosciences, Inc.
Organization:
Study Overview
Official Title:
A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
Status:
COMPLETED
Status Verified Date:
2017-03
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 Phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.
Detailed Description:
This study will examine the safety and tolerability of AVB-620 administered as an IV infusion to women with primary, non-recurrent breast cancer undergoing surgery. The study will also characterize the pharmacokinetics of AVB-620 in this subject population and determine the dose of AVB-620 needed to generate a fluorescence signal in tumor and lymph node tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of AVB-620 administration, relative to surgery, on fluorescence characteristics.
Study Oversight
Has Oversight DMC:
False
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?: