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New treatment option for Advanced Solid Tumor
Official title Metformin Combined With Chemotherapy and/or Immunotherapy in Solid Malignancies
ClinicalTrials.gov ID: NCT07098299
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as an once-daily, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate the safety of Metformin alone and in combination with chemotherapy or immunotherapy in patients with solid tumor cancers. The main questions it aims to answer are: what are the toxicities of metformin at multiple dose levels what is the maximum tolerated dose of Metformin in combination with chemotherapy or immunotherapy Participants enrolled will be treated with standard of care chemotherapy and/or immunotherapy in accordance to their disease/stage.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have histologically confirmed advanced solid tumor and are considered a suitable candidate for chemotherapy and/or immunotherapy or both
- Are a male or female participant aged ≥ 18 years
- Have provided a signed, written informed consent form
- Have measurable disease per RECIST v1.1
- Have adequate hematologic, renal, liver, and coagulation function as defined by the following:
You likely can't join if
- Patients who have or are any of the following exclusion criteria are not eligible for participation in the study.
- Patients with uncontrolled diabetes
- Patients who have received metformin must be at least five half-lives beyond such treatment (four weeks) and must not be taking metformin at the time...
- Patients with a known hypersensitivity to metformin, its excipients, its analogs, or any of its components
- Patients on other antidiabetic medicines are eligible as long as adding metformin will not be contraindicated
- Patients with an inability to tolerate oral medications
See the full eligibility criteria
- Have histologically confirmed advanced solid tumor and are considered a suitable candidate for chemotherapy and/or immunotherapy or both
- Are a male or female participant aged ≥ 18 years
- Have provided a signed, written informed consent form
- Have measurable disease per RECIST v1.1
- Have adequate hematologic, renal, liver, and coagulation function as defined by the following:
- Hemoglobin ≥ 8 g/dL if determined suitable by the investigator for the selected chemotherapy and/or immunotherapy regimen for the particular patient
- Absolute neutrophil count (ANC) \> 1500/mm3
- Platelets \> 75,000/mm3 if determined suitable by the investigator for the selected chemotherapy and /or immunotherapy regimen for the particular patient
- Estimated Glomerular Filtration Rate (eGFR) \> 45 mL/min/1.73 m2 (as described by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021 equation)
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN). Participants with known Gilbert's syndrome who have total bilirubin level ≤ 3 x ULN may be enrolled if deemed suitable for a particular patient by the investigator...
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 x ULN. For participants with hepatic metastases, AST and ALT ≤ 5 x ULN.
- Alkaline phosphatase (ALP) \< 2.5 x ULN. For participants with hepatic and/or bone metastases ≤ 5 x ULN
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2, and suitable for chemotherapy/IO recommended by the investigator.
- Participants who have experienced expected toxicity from Cycle 1 of anticancer therapy which is unlikely to recover to grade 1 or better prior to Cycle 2 (e.g., anemia, alopecia, vitiligo, endocrine dysfunction...
- Women of child-bearing potential must agree to avoid becoming pregnant and male participants should avoid impregnating a female partner or donating sperm starting at initiation of treatment up until at least 90 days...
- Have an estimated life expectancy of at least 12 weeks
- Patients who have or are any of the following exclusion criteria are not eligible for participation in the study.
- Patients with uncontrolled diabetes
- Patients who have received metformin must be at least five half-lives beyond such treatment (four weeks) and must not be taking metformin at the time of enrollment.
- Patients with a known hypersensitivity to metformin, its excipients, its analogs, or any of its components
- Patients on other antidiabetic medicines are eligible as long as adding metformin will not be contraindicated
- Patients with an inability to tolerate oral medications
- Women who are pregnant or lactating
- Patients with clinically significant intercurrent disease including, but not limited to:
- New York Heart Association Class III or IV heart failure
- Myocardial infarction, unstable angina, or stroke ≤ 3 months prior to Cycle 1 Day 1
- Uncontrolled arrhythmia
- Clinically significant active infection requiring IV antibiotic, antiviral, or antifungal medications
- Patients with other current medical or other conditions that, in the opinion of the investigator, may confound study interpretation or prevent completion of study procedures and follow-up examinations
- Patients with an unwillingness or inability to comply with the study procedures required in this protocol
- Patients using an investigational agent within four weeks of study entry
- Patients with uncontrolled metabolic disorders or primary or secondary effects of cancer that induce a high medical risk
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.