Metformin for Soft Tissue Sarcoma

Not yet recruiting at 1 trial location

Overseen By Leah Wilson, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Wake Forest University Health Sciences

Must not be taking: CYP450 inhibitors/inducers

Disqualifiers: Metabolic acidosis, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years or until early treatment discontinuation

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if metformin, a common diabetes medication, can improve outcomes for patients with metastatic soft tissue sarcoma when combined with their usual cancer treatment. Researchers are exploring whether adding metformin enhances the effectiveness of standard treatment for those with cancer that has spread. The trial seeks participants with advanced soft tissue sarcoma who are about to start or have recently started their first systemic therapy for this condition. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that metformin is likely to be safe for humans?

Research shows that metformin is generally safe for use. It is a common drug for managing type 2 diabetes and has a strong safety record. Metformin's safety and effectiveness have been proven in both adults and children aged 10 to 16 years for managing diabetes.

Some studies suggest that metformin might help people with soft tissue sarcoma, a type of cancer. Specifically, patients taking metformin at the time of their cancer diagnosis had a lower risk of death compared to those not taking it.

Regarding side effects, metformin can cause mild digestive issues like nausea or diarrhea, especially when first starting or increasing the dose. In this trial, researchers will begin with a lower dose to assess tolerance before increasing the amount. Overall, evidence suggests that metformin is quite safe for use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for soft tissue sarcoma?

Metformin is unique in treating advanced soft tissue sarcoma because it’s traditionally used for diabetes, not cancer. Researchers are excited about its potential because it targets cancer cells differently by impacting their metabolism, something current chemotherapy treatments don’t do. Additionally, metformin is taken orally, making it more convenient compared to many cancer treatments that require intravenous administration. This new approach could offer a complementary angle to existing therapies, possibly enhancing their effectiveness.

What evidence suggests that metformin might be an effective treatment for soft tissue sarcoma?

Research has shown that metformin, a drug often used for diabetes, might help people with soft tissue sarcoma, a type of cancer, live longer. Studies found that patients with this cancer who took metformin lived slightly longer than those who did not. In this trial, participants will receive metformin in combination with physician-directed standard-of-care systemic therapy for advanced unresectable or metastatic soft tissue sarcoma. Researchers believe metformin helps by altering how the body uses energy and possibly slowing cancer growth. It has also shown promise in treating other cancers, such as lung and prostate cancer. Although the exact mechanism of metformin's effect is still under investigation, early results are encouraging for its use alongside regular cancer treatments. ^{1 2 5 6 7}

Who Is on the Research Team?

Megan Jagosky, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

Adults with advanced, inoperable or metastatic soft tissue sarcoma who haven't started first-line therapy or are within 4 weeks of starting it. They must have good kidney and liver function, not be pregnant or planning to conceive, and willing to use effective contraception. Exclusions include breastfeeding individuals, those free from another cancer for less than five years, recent investigational drug users, metformin allergy sufferers, uncontrolled illness patients, those with brain/CNS metastases or a history of metabolic acidosis.

Inclusion Criteria

I can have children and have a recent negative pregnancy test.

My sarcoma cannot be removed by surgery and is advanced.

ICBP and partners of ICBP must not be expecting to conceive and be willing to use a highly effective contraceptive method

Exclusion Criteria

Planned enrollment on a treatment clinical trial for first line therapy

Breastfeeding within the duration of anticipated study treatment

I have been cancer-free from another type of cancer for at least 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive metformin in combination with standard of care systemic therapy for advanced unresectable or metastatic soft tissue sarcoma

5 years or until early treatment discontinuation

Regular visits for dose assessment and monitoring

Dose Adjustment

Toleration of the starting dose of metformin is assessed, and dose is adjusted based on toleration criteria

14 days

Office visit for dose assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

• Metformin Hydrochloride

Trial Overview

This study tests the effectiveness of Metformin Hydrochloride ER when combined with standard care treatments for soft tissue sarcoma that has spread. The goal is to see if adding Metformin improves outcomes compared to standard treatment alone.

How Is the Trial Designed?

Group I: Arm A Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Paula Takacs Foundation

Collaborator

Atrium Health Levine Cancer Institute

Collaborator

Trials

30

Recruited

4,700+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8923596/

Is Metformin Use Associated with Prolonged Overall ...

Patients treated for soft tissue sarcoma while taking metformin had modestly prolonged survival compared with their counterparts who did not take metformin, ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07291297?term=NA

Study Details | NCT07291297 | Metformin Hydrochloride in ...

Metformin Hydrochloride in Combination With Standard of Care ... (cancer that has spread) soft tissue sarcoma can improve patient outcomes.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8923598/

Is Metformin Use Associated with Prolonged Overall ...

Metformin may increase survival in a wide variety of carcinomas such as lung, prostate, colorectal, and endometrial origin.

4.

ctv.veeva.com

ctv.veeva.com/study/metformin-hydrochloride-in-combination-with-standard-of-care-systemic-therapy-in-previously-untreate

Metformin Hydrochloride in Combination With Standard of ...

The purpose of this research study is to see how metformin ... (cancer that has spread) soft tissue sarcoma can improve patient outcomes.

5.

researchgate.net

researchgate.net/publication/356239652_Is_Metformin_Use_Associated_With_Prolonged_Overall_Survival_In_Patients_with_Soft_Tissue_Sarcoma_A_Surveillance_Epidemiology_and_End_Results-Medicare_Study

Is Metformin Use Associated With Prolonged Overall ...

Background: Metformin, an oral drug used to treat patients with diabetes, has been associated with prolonged survival in patients with various visceral ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf

GLUCOPHAGE® (metformin hydrochloride) Tablets

The safety and effectiveness of GLUCOPHAGE for the treatment of type 2 diabetes have been established in pediatric patients ages 10 to 16 years (studies have ...

7.

vionausa.com

vionausa.com/wp-content/uploads/2020/01/SDS-Metformin-HCl-ER-Tablets.pdf

SAFETY DATA SHEET Metformin Hydrochloride Extended ...

Risk Summary. Limited data with metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for.