Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04781725
Status:
UNKNOWN
Last Update Posted:
2021-11-17
First Post:
2021-01-25
Brief Title:
INVINCIBLE TRIAL Intratumoral INT230-6 in 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 Intratumoral INT230-6 in Early Stage Breast Cancer The INVINCIBLE Trial
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
RECRUITING
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 II randomized multi-center parallel design window of opportunity trial evaluating intratumoral INT230-6 in up to 90 patients with early stage breast cancer In a 21 randomization patients on the treatment arm will receive intratumoral INT230-6 injections prior to breast surgery
Detailed Description:
The study comprises 2 consecutive parts The first part will be to test safety and feasibility of the dosing procedures Results from Part I of the study will standardise the optimal dose and frequency of INT230-6 for participants in Part II
Part I Open-label 21 randomized study of up to 30 patients Treatment arm patients will be given up to 3 doses of INT230-6 injected weekly prior to breast surgery at a dose based on longest diameter The control arm patients receive no treatment
Part II Double-blind 21 randomized study of up to an additional 60 patients The placebo arm includes a saline injection of similar dose and frequency as the treatment arm up to 2 doses of INT230-6saline injected weekly prior to breast surgery
Part I Open-label 21 randomized study of up to 30 patients Treatment arm patients will be given up to 3 doses of INT230-6 injected weekly prior to breast surgery at a dose based on longest diameter The control arm patients receive no treatment
Part II Double-blind 21 randomized study of up to an additional 60 patients The placebo arm includes a saline injection of similar dose and frequency as the treatment arm up to 2 doses of INT230-6saline injected weekly prior to breast surgery
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?:
True
Is an FDA AA801 Violation?:
None