Actively Recruiting
Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in 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
395 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
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.
CONDITIONS
Official 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, either not yet started but planning to within 4 weeks or started within the past 4 weeks
- Adequate performance status (ECOG PS 0-2)
- Adequate kidney function
- Adequate liver function
- Negative pregnancy test within 7 days before enrollment for individuals who can become pregnant
- Willingness to use highly effective contraception during and for 30 days after treatment for individuals who can become pregnant and their partners
- Willingness to use condoms if having sexual relationships where partner may become pregnant during and for 30 days after treatment
- Ability to take oral medications
You will not qualify if you...
- Already taking metformin at diagnosis of advanced unresectable or metastatic disease
- Planned enrollment on another first-line treatment clinical trial
- Breastfeeding during study treatment
- History of acute or chronic metabolic acidosis including diabetic ketoacidosis
- Other cancers within past 5 years except certain skin or in situ cancers
- Use of investigational drugs within 14 days before starting treatment
- Allergic reactions to metformin or similar compounds
- Use of medications that affect CYP450 enzymes that interact with metformin
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, arrhythmia, 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
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
CONTACT
M
Megan Jagosky, MD
CONTACT
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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