Metformin for Cancer

Overseen By Wasif Saif, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Barbara Ann Karmanos Cancer Institute

Must not be taking: Metformin

Disqualifiers: Uncontrolled diabetes, Heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 4 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of using Metformin, a common diabetes medication, to help treat individuals with solid tumor cancers. Researchers aim to determine the optimal dose of Metformin when combined with standard cancer treatments like chemotherapy and immunotherapy. Participants will take Metformin alone for a short period before combining it with other cancer treatments to assess tolerance. This trial may suit those with advanced solid tumors who are already receiving or planning to receive chemotherapy or immunotherapy. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking cancer research.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does mention that patients on other antidiabetic medicines can participate as long as adding metformin is not contraindicated (not advised). It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that metformin is generally safe, as it is often used to treat diabetes. In past studies, people with diabetes who took metformin had a lower chance of developing cancer. However, combining metformin with chemotherapy for cancer patients has not significantly improved survival rates.

Most studies report no serious safety issues with metformin. Some individuals might experience mild side effects like an upset stomach or diarrhea, but these are usually manageable. Since this trial is in an early stage, the researchers aim to learn more about how well people can tolerate metformin, especially when combined with cancer treatments like chemotherapy and immunotherapy. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Metformin is unique because it’s traditionally used as a diabetes medication but is now being explored for its potential in cancer treatment. Researchers are excited about this treatment because it could enhance the effectiveness of standard chemotherapy or immunotherapy by altering cancer cell metabolism, essentially starving the cancer cells of the energy they need to grow. Unlike most cancer treatments that directly target cancer cells, metformin works by impacting the tumor environment, which might lead to fewer side effects and improved patient outcomes.

What evidence suggests that Metformin might be an effective treatment for solid tumor cancers?

Studies have shown that Metformin, a common diabetes medication, might help cancer patients live longer, particularly those with breast, pancreatic, and lung cancers. Some research suggests that people with diabetes who take Metformin and also have cancer may benefit from its protective effects. This trial will administer Metformin in combination with any standard chemotherapy or immunotherapy. In certain studies, patients experienced significant improvements in survival when Metformin was used alongside standard chemotherapy. Additionally, Metformin has been associated with a lower overall risk of developing cancer. These findings suggest that Metformin could enhance cancer treatment outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Wasif Saif, M.D.

Principal Investigator

Wayne State University

Are You a Good Fit for This Trial?

Adults with advanced solid tumors suitable for chemotherapy and/or immunotherapy can join this trial. They must have a certain level of hemoglobin, white blood cells, platelets, kidney function (eGFR > 45 mL/min/1.73 m2), and liver enzymes within specific limits. Participants need measurable disease per RECIST v1.1 criteria.

Inclusion Criteria

My cancer can be measured by standard health scans.

I am 18 years old or older.

I have signed a consent form for the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Metformin Run-in

Participants take Metformin alone for 14 days to determine tolerability

2 weeks

Treatment

Participants receive Metformin daily in combination with standard chemotherapy and/or immunotherapy

Up to 4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Metformin

Trial Overview The trial is testing the safety of Metformin when used alone or with standard cancer treatments like chemo or immunotherapy in patients with solid tumors. It will determine the highest dose that doesn't cause severe side effects by first giving Metformin alone, then alongside other treatments from cycle two onwards.

How Is the Trial Designed?

Group I: Metformin Experimental Treatment 1 Intervention

Metformin will be administered in combination with any standard chemotherapy/immunotherapy. Metformin 1000mg-3000mg day in dose escalation

Who Is Running the Clinical Trial?

Barbara Ann Karmanos Cancer Institute

Lead Sponsor

Trials

166

Recruited

9,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9750609/

Prognostic value of metformin in cancers: An updated meta ... It showed that the use of metformin has a significant impact on the overall survival of breast, pancreatic, and lung cancer. Summary data of other tumors were ...

2. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-023-04263-8

Metformin and cancer hallmarks: shedding new lights on ... Epidemiological studies have revealed that metformin exerts protective effects on people with diabetes suffering from cancer [10,11,12].

3. diabetesjournals.org diabetesjournals.org/care/article/46/5/904/148773/Metformin-and-Cancer-Solutions-to-a-Real-World

Metformin and Cancer: Solutions to a Real-World Evidence ... Concurrently, multiple nonrandomized observational studies reported remarkable reductions in cancer incidence and outcomes with metformin use.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0753332225007012

From basics to clinics: New opportunities for metformin in ... A pooled analysis of two Phase II clinical trials showed that metformin combined with platinum-based chemotherapy resulted in significant survival improvement ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4154969/

Metformin and Cancer Risk and Mortality: A Systematic ... The main results from our study show that metformin use is associated with decreased overall cancer incidence even after adjustment for BMI or time-related ...

6. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1176885/full

Efficacy and safety of metformin in combination with ... We found that chemotherapy in combination with metformin in cancer patients without diabetes did not prolong progression-free survival and overall survival.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0300908425000562

Metformin's anticancer odyssey: Revealing multifaceted ... Assessments of the safety and efficacy of metformin for cancer treatment are lacking significant laboratory and clinical data [133]. Notwithstanding these ...