NCT07291297

Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic Soft Tissue Sarcoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to see how metformin, when used in combination with standard of care (SOC) treatment for metastatic (cancer that has spread) soft tissue sarcoma can improve patient outcomes.

Detailed description

This is a single arm, phase II, open-label study of metformin in combination with physician directed SOC first-line systemic therapy in participants with advanced unresectable or metastatic STS. Participants will continue study treatment for 5 years or until early treatment discontinuation. Metformin treatment intervention should begin no later than 4 weeks from the initiation of front-line SOC therapy. Participants will initially take 1000mg ER of metformin by mouth daily for 14 days, in combination with physician directed SOC systemic therapy for advanced unresectable or metastatic STS. Toleration of the starting dose of metformin at 1000mg ER daily will be assessed during an office visit with the treating provider prior to Course1-D15. Toleration of the 1000mg ER daily dose will be defined by the participant meeting all criteria below at the Course 1-Day15 (+ 7 days) study visit: * No grade 3/4 metformin-related toxicities since initiation of metformin * No metformin-related GI upset since initiation of metformin including diarrhea * Acceptable organ function * The treating provider must agree the participant has sufficiently tolerated the starting dose of the treatment intervention. If toleration has been deemed acceptable, by meeting all criteria above as outlined, the metformin dose will be increased from 1000mg ER daily to 1000mg ER twice a day starting on Course1-D15. If the participant does not meet all criteria above for dose escalation, the participant will continue to receive 1000mg ER daily.

Conditions

• Sarcoma Metastatic
• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
DRUG	Metformin Hydrochloride ER	Participants will initially take 1000mg ER of metformin by mouth daily for 14 days, in combination with physician directed SOC systemic therapy for advanced unresectable or metastatic STS.

Timeline

• Start date: 2026-03-04
• Primary completion: 2028-10-01
• Completion: 2033-10-01
• First posted: 2025-12-18
• Last updated: 2026-03-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study