About this trial
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 criteria
Qualifiers
Advanced unresectable or metastatic/intermediate/high grade soft tissue sarcoma
Age ≥ 18 years at the time of enrollment
Initiating first line systemic therapy for advanced/metastatic disease (treatment naïve for advanced/metastatic disease)
Participants who have not yet initiated first line systemic therapy: expected to initiate front-line therapy within 4 weeks of initiating metformin
Disqualifiers
Already prescribed and taking metformin at time of diagnosis of advanced unresectable or metastatic disease
Planned enrollment on a treatment clinical trial for first line therapy
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.
History of acute or chronic metabolic acidosis including diabetic ketoacidosis, with or without coma.
Trial design
Treatments tested in this trial
- Metformin Hydrochloride ER
Treatment groups
Sponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
Atrium Health Levine Cancer Institute
Collaborator
Paula Takacs Foundation
Collaborator