RecruitingPhase 2NCT07291297

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


Sponsor

Wake Forest University Health Sciences

Enrollment

50 participants

Start Date

Mar 4, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding metformin (a diabetes drug being investigated for anti-cancer properties) to standard first-line chemotherapy improves outcomes for people with advanced soft tissue sarcoma, a cancer that forms in muscles, fat, or connective tissue. **You may be eligible if...** - You are 18 or older - You have advanced, unresectable or metastatic intermediate-to-high grade soft tissue sarcoma - You are about to start or have just started your first chemotherapy regimen for advanced/metastatic disease (within 4 weeks) - You are in good general health (ECOG 0–2) - Your kidney and liver function are adequate **You may NOT be eligible if...** - You have already received chemotherapy for advanced or metastatic disease (beyond the 4-week window) - You have kidney, liver, or other organ dysfunction that makes metformin unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin 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.


Locations(2)

Levine Cancer Institute

Charlotte, North Carolina, United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

View Full Details on ClinicalTrials.gov

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NCT07291297


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