Home › Trials › NCT07291297
Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 18 and up

Metformin plus standard first-line therapy for advanced soft tissue sarcoma

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

Run by Wake Forest University Health Sciences · NCT07291297 · Data updated 2026-11-12

This trial tests whether adding metformin to standard first-line systemic treatment helps people with previously untreated advanced or metastatic soft tissue sarcoma.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorWake Forest University Health Sciences
Academic / other
Locations2 sites (Charlotte, North Carolina and 1 other locations)
StatusRecruiting
StartedMarch 4, 2026
Main results expectedOctober 2028
Study endsOctober 2033
Registry record updatedJuly 23, 2026
Trial IDNCT07291297 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with previously untreated advanced unresectable or metastatic intermediate/high-grade soft tissue sarcoma who are starting first-line systemic therapy, have ECOG 0–2, and adequate kidney and liver function are ideal candidates.

Probably not a fit

Patients who have already received systemic therapy for metastatic disease, have poor organ function, significant renal impairment, cannot tolerate metformin, or are pregnant are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label Phase II study testing extended-release metformin given alongside physician-directed standard-of-care first-line systemic therapy for adults with advanced unresectable or metastatic soft tissue sarcoma. Participants start metformin 1000 mg ER daily for 14 days and, if tolerated, escalate to 1000 mg ER twice daily beginning around Day 15, with tolerability assessed clinically and by organ-function tests. Treatment continues for up to five years or until early discontinuation, and metformin must begin within four weeks of initiating front-line systemic therapy. Eligible participants are adults with intermediate/high-grade advanced or metastatic soft tissue sarcoma, ECOG performance status 0–2, and adequate renal and hepatic function.

Why it matters

Potential benefit: If successful, adding metformin may improve clinical outcomes such as response rates or progression-free survival for patients with advanced soft tissue sarcoma.

How similar studies have gone: Metformin has shown mixed signals in other cancer types with some promising preclinical data, but randomized evidence specifically in advanced soft tissue sarcoma is very limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Advanced unresectable or metastatic/intermediate/high grade soft tissue sarcoma
2. Age ≥ 18 years at the time of enrollment
3. Initiating first line systemic therapy for advanced/metastatic disease (treatment naïve for advanced/metastatic disease)

   1. Participants who have not yet initiated first line systemic therapy: expected to initiate front-line therapy within 4 weeks of initiating metformin
   2. Participants who have previously initiated first line systemic therapy: No more than 4 weeks from initiation of first line systemic therapy
4. Adequate performance status (PS) defined as ECOG PS = 0-2
5. Adequate renal function
6. Adequate liver function
7. Individuals of childbearing potential (ICBP) must have a negative serum pregnancy test within 7 days prior to enrollment. NOTE: Individuals who may become pregnant are considered to have childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause). Metformin is known to be excreted in breast milk and should not be used by nursing mothers.
8. ICBP and partners of ICBP must not be expecting to conceive and be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of \<1% per year when used consistently and correctly) from the time of informed consent until 30 days after study treatment discontinuation.
9. Individuals who are having sexual relationships in which their partners may become pregnant must be willing to use condoms from the time of informed consent until 30 days after study treatment discontinuation. For a non-pregnant ICBP partner, contraception recommendations should also be considered.
10. Ability to ingest oral medications

Exclusion Criteria:

1. Already prescribed and taking metformin at time of diagnosis of advanced unresectable or metastatic disease
2. Planned enrollment on a treatment clinical trial for first line therapy
3. Breastfeeding within the duration of anticipated study treatment. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.
4. History of acute or chronic metabolic acidosis including diabetic ketoacidosis, with or without coma.
5. Participants previously diagnosed with an additional malignancy must be disease-free for at least five years prior to enrollment. Exceptions include ductal carcinoma in situ (DCIS), basal cell or squamous cell skin cancer and in situ cervical or bladder cancer.
6. Treatment with any investigational drug within 14 days prior to day 1 of treatment
7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin. Participants receiving any medications or substances that are inhibitors or inducers of CYP450 enzyme(s) are ineligible. Lists including medications and substances known or with the potential to interact with the specified CYP450 enzyme(s) isoenzymes. Please refer to https://drug-interactions.medicine.iu.edu/MainTable.aspx for the most current information.
8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure requiring pharmacologic treatment, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator.
9. Patients with known brain or active central nervous system (CNS) metastases.

Where it's running

  • Levine Cancer Institute
    Charlotte, North Carolina, United States     Recruiting
  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center
    Winston-Salem, North Carolina, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Sarcoma Metastatic 5Sarcoma, Soft Tissue 6Wake Forest University Health Sciences 669
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.