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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

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

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Wake Forest University Health Sciences

Lead sponsor

Atrium Health Levine Cancer Institute

Collaborator

Paula Takacs Foundation

Collaborator