Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic Soft Tissue Sarcoma
Wake Forest University Health Sciences
Summary
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.
Description
This is a single arm, phase II, open-label study of metformin in combination with physician directed SOC first-line systemic therapy in participants with advanced unresectable or metastatic STS. Participants will continue study treatment for 5 years or until early treatment discontinuation. Metformin treatment intervention should begin no later than 4 weeks from the initiation of front-line SOC therapy. Participants will initially take 1000mg ER of metformin by mouth daily for 14 days, in combination with physician directed SOC systemic therapy for advanced unresectable or metastatic STS. Tol…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 sta…
Interventions
- DrugMetformin Hydrochloride ER
Participants will initially take 1000mg ER of metformin by mouth daily for 14 days, in combination with physician directed SOC systemic therapy for advanced unresectable or metastatic STS.
Locations (2)
- Levine Cancer InstituteCharlotte, North Carolina
- Atrium Health Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, North Carolina