Ignite Creation Date:
2024-05-06 @ 2:01 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04197999
Status:
TERMINATED
Last Update Posted:
2022-03-22
First Post:
2019-12-04
Brief Title:
A Study to Determine Safety and Tolerability of GMI-1359 in Subjects With HR Metastatic Breast Cancer
Sponsor:
GlycoMimetics Incorporated
Organization:
GlycoMimetics Incorporated
Study Overview
Official Title:
A Phase 1b Single and Multiple Dose Open-Label Trial of Intravenous GMI-1359 in HR Metastatic Breast Cancer Subjects
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
After demonstrating the on target effect of GMI-1359 via pharmacodynamic markers CXCR4 and E-selectin Sponsor terminated the trial due to COVID-related slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is being conducted to investigate the safety tolerability pharmacokinetics the effect the body has on the drug and pharmacodynamics the effect the drug has on the body of GMI-1359 when given with standard-of-care treatment to subjects with HR metastatic breast cancer
Detailed Description:
None
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