Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04676516
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2020-07-28
Brief Title:
A Phase II Window of Opportunity Trial of PRMT5 Inhibitor GSK3326595 in Early Stage Breast Cancer
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
A Phase II Randomized Window of Opportunity Trial Evaluating Clinical and Biological Effects of PRMT5 Inhibitor GSK3326595 in Early Stage Breast Cancer
Status:
COMPLETED
Status Verified Date:
2022-10
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:
OTT-19-06
Brief Summary:
This is a Phase II Randomized Window of Opportunity Trial Evaluating Clinical and Biological effects of PRMT5 inhibitor GSK3326595 in Early Stage Breast Cancer
Detailed Description:
This is a phase II randomized open label multi-center parallel design window of opportunity trial in up to 60 patients with early stage Hormone Receptor HR positive breast cancer evaluating GSK3326595 In a 21 randomization patients will receive GSK3326595no treatment for 15 - 3 days prior to breast surgery There is no placebo in this trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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