Metformin with Standard Therapy for Advanced Soft Tissue Sarcoma

This study is looking at how adding Metformin Hydrochloride to your regular (standard of care) treatment might help people with advanced soft tissue sarcoma that cannot be removed by surgery or has spread (metastatic). We want to see if this combination improves how long people live. You might be able to join if you are 18 or older, have advanced soft tissue sarcoma, and are about to start your first systemic treatment for this advanced disease. The study aims to enroll 50 participants and will measure how many participants are still alive at 12 months after starting Metformin.

Study design
This is a single-arm study, meaning everyone receives the same treatment. It is open-label, so you and your doctor will know you are receiving Metformin. The study plans to include 50 participants.
What's involved
You will take Metformin Hydrochloride by mouth daily for up to 5 years or until your treatment is stopped early. You will also have an office visit around 15 days after starting Metformin to check how you are tolerating the dose.
Compensation
Not stated in the trial record.
Follow-up
The study will track how long participants survive for at least 12 months from the start of Metformin.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07291297

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Wake Forest University Health Sciences
~50 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Metformin Hydrochloride ER

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants surviving at 12 months
Measured over From date of metformin start to date of death, or censored at 12 months, whichever occurred first.
Sarcoma Metastatic
Sarcoma, Soft Tissue
2 sites across 1 states
North Carolina2
  • Megan Jagosky, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

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  • Number of participants surviving at 12 monthsFrom date of metformin start to date of death, or censored at 12 months, whichever occurred first.

    12-month overall survival (OS) will be determined for each participant as a binary variable indicating whether the participant was surviving at 12 months after study enrollment. Failure occurs if the participant dies from any cause within 12 months of study enrollment (initiation of metformin).