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

NCT07291297 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-05

No results posted yet for this study

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.

Conditions

  • Sarcoma Metastatic
  • Sarcoma, Soft Tissue

Interventions

DRUG

Metformin 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.

Sponsors & Collaborators

  • Atrium Health Levine Cancer Institute

    collaborator OTHER
  • Paula Takacs Foundation

    collaborator UNKNOWN
  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Megan Jagosky, MD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-04
Primary Completion
2028-10-31
Completion
2033-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07291297 on ClinicalTrials.gov