Actively Recruiting
Metformin Hydrochloride Combined With Standard Systemic Therapy for Previously Untreated Advanced Unresectable or Metastatic Soft Tissue Sarcoma
Led by Wake Forest University Health Sciences · Updated on 2026-03-05
50
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
A
Atrium Health Levine Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how metformin, when combined with standard care treatment, may affect outcomes for patients with advanced, unresectable, or metastatic soft tissue sarcoma. This phase II, open-label study focuses on participants who have not yet been treated for their advanced disease, aiming to understand the impact of adding metformin to first-line systemic therapy. The study is sponsored by Wake Forest University Health Sciences and intends to follow participants for up to 5 years or until early treatment stops. Participants will start by taking 1000mg of extended-release metformin by mouth daily for 14 days alongside physician-directed standard systemic therapy. Around day 15 of the first treatment course, researchers will assess how well the participant tolerates this dose based on specific health criteria and side effects. If tolerated well, the metformin dose will be increased to 1000mg twice daily; if not, the daily dose will remain at 1000mg. This dosing regimen is combined with ongoing standard care throughout the study period. During the study, participants will have regular visits to monitor treatment tolerance, including assessments of side effects and organ function. The primary outcome measured is survival at 12 months from the start of metformin treatment. Secondary outcomes include overall survival and cancer-specific survival, both tracked for about 5 years. Participants will also undergo routine evaluations to ensure safety and adherence to the treatment plan during this extended follow-up.
CONDITIONS
Brief Title
Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Advanced unresectable or metastatic/intermediate/high grade soft tissue sarcoma
- Age 18 years or older at enrollment
- Starting first-line systemic therapy for advanced/metastatic disease (treatment-naïve for advanced disease)
- Participants not yet started first-line therapy must begin within 4 weeks of metformin start
- Participants who started first-line therapy must be within 4 weeks of initiation
- Adequate performance status (ECOG 0-2)
- Adequate kidney function
- Adequate liver function
- Negative pregnancy test within 7 days before enrollment for individuals of childbearing potential
- Willingness to use effective contraception during and 30 days after study treatment
- Ability to take oral medications
You will not qualify if you...
- Already taking metformin at diagnosis of advanced disease
- Planning to enroll in another first-line treatment clinical trial
- Breastfeeding during study treatment
- History of metabolic acidosis including diabetic ketoacidosis
- Other cancers diagnosed within past 5 years except certain skin and cervical cancers
- Use of investigational drugs within 14 days before treatment start
- Allergic reactions to metformin or related compounds
- Use of medications that affect CYP450 enzymes
- Uncontrolled illnesses such as active infections, heart failure, unstable angina, arrhythmias, or psychiatric/social issues limiting compliance
- Known brain or active central nervous system metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years or until early discontinuation
Participants take metformin in combination with physician directed standard of care systemic therapy for advanced unresectable or metastatic soft tissue sarcoma. They start with 1000mg ER metformin daily for 14 days, followed by possible dose escalation to 1000mg ER twice daily depending on toleration assessed at a visit around day 15. Participants continue treatment for up to 5 years or until early discontinuation.
At least 1 visit prior to Day 15 and ongoing visits as directed by the treating provider
Trial Site Locations
Total: 2 locations
1
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
2
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
Research Team
L
Leah Wilson, RN
M
Megan Jagosky, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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