NCT05689619

SILibinin in NSCLC and BC Patients With Single Brain METastasis (SILMET)

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: A.O.U. Città della Salute e della Scienza · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 1:1 to silibinin 1 g/day taken orally in comparison with oral placebo 1 g/day. A contrast-enhanced brain MRI will be performed every 8 weeks to evaluate intracranial local and distance recurrence

Conditions

• Brain Metastases, Adult
• Non Small Cell Lung Cancer
• Breast Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Silibinin	Silibinin 1 g/day taken orally plus standard systemic therapy for NSCLC or BC
OTHER	Placebo	Placebo 1 g/day taken orally plus standard systemic therapy for NSCLC or BC

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-09-01
• Completion: 2027-09-01
• First posted: 2023-01-19
• Last updated: 2023-12-15

Locations

6 sites across 1 country: Italy