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

Conditions

• Sarcoma Metastatic
• Sarcoma, Soft Tissue

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Metformin Hydrochloride ER — DRUG
  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.

Study Details

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.

Key Dates

Start date

Mar 4, 2026

Status verified

Mar 2026

Primary completion

Oct 31, 2028

Completion

Oct 31, 2033

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: Metformin Hydrochloride ER
  1000mg early release (ER) of metformin by mouth daily for 14 days, in combination with physician directed SOC systemic therapy for advanced unresectable or metastatic STS. Toleration of the starting dose of metformin at 1000mg ER daily will be assessed during an office visit with the treating provider prior to Course1-D15. If toleration has been deemed acceptable, the metformin dose will be increased from 1000mg ER daily to 1000mg ER twice a day starting on Course1-D15. If the participant does not meet all criteria for dose escalation, the participant will continue to receive 1000mg ER daily.

Primary Outcome Measure

Number of participants surviving at 12 months [ Time Frame: From date of metformin start to date of death, or censored at 12 months, whichever occurred first. ]

Central Contacts

• Leah Wilson, RN
  980-442-2333
  [email protected]
• Megan Jagosky, MD
  704-446-1242
  [email protected]

Locations (2)

Find similar trials in Charlotte, NC

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