Is NCT07098299 recruiting in Detroit, MI?

Yes, NCT07098299 is currently recruiting participants at its Detroit, MI location. This advanced solid tumor clinical trial is actively enrolling qualified participants.

How do I join the advanced solid tumor clinical trial in Detroit?

To join this clinical trial in Detroit, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Detroit clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Advanced Solid Tumor Clinical Trial in Detroit, MI

About This Advanced Solid Tumor Study in Detroit

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. In addition, participants will take Metformin alone for 14 days in between the first cycle of chemotherapy and the second cycle of chemotherapy to determine tolerability to the Metformin. Participants will then take Metformin daily in combination with the standard of care chemotherapy and/or Immunotherapy from cycle 2 onwards.

Sponsor: Barbara Ann Karmanos Cancer Institute

Who Can Participate

Inclusion 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 for the selected chemotherapy and/or immunotherapy regimen.

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 associated with IO) and may otherwise not impact the eligibility will be allowed.

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 after the last dose of study drug.

Have an estimated life expectancy of at least 12 weeks

Exclusion Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Detroit?

Yes, this clinical trial (NCT07098299) has an active research site in Detroit, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Solid Tumor Treatment Options in Detroit, MI

If you're searching for advanced solid tumor treatment options in Detroit, MI, this clinical trial (NCT07098299) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Detroit research site is actively enrolling participants for this clinical trial. You'll receive care from experienced advanced solid tumor specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced solid tumor clinical trials near you to find additional studies recruiting in your area.

Advanced Solid Tumor Clinical Trial in Detroit, MI

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