Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05689619
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-01-04
Brief Title:
SILibinin in NSCLC and BC Patients With Single Brain METastasis SILMET
Sponsor:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Organization:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Study Overview
Official Title:
A Phase 2 Randomized Multicenter Trial on Silibinin To Prevent Intracranial Recurrence After Gross-Total Resection of Single Brain Metastasis From Non-Small Cell Lung Cancer or Breast Cancer
Status:
RECRUITING
Status Verified Date:
2023-12
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:
SILMET
Brief Summary:
This study aims to evaluate the efficacy of silibinin in preventing recurrence in the brain after complete resection of a brain metastasis BM from non-small-cell lung cancer NSCLC or breast cancer BC
Detailed Description:
This is the first placebo-controlled study evaluating the efficacy of silibinin as STAT3 inhibitor in preventing recurrence in the brain after gross-total resection of a brain metastasis BM from non-small-cell lung cancer NSCLC or breast cancer BC
Participants will be randomized 11 to silibinin 1 gday taken orally in comparison with oral placebo 1 gday A contrast-enhanced brain MRI will be performed every 8 weeks to evaluate intracranial local and distance recurrence
Participants will be randomized 11 to silibinin 1 gday taken orally in comparison with oral placebo 1 gday A contrast-enhanced brain MRI will be performed every 8 weeks to evaluate intracranial local and distance recurrence
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