Fanconi Anemia study: Metformin vs Naproxen Sodium
Official title Safety and Tolerability of Metformin and Naproxen for Cancer Prevention in Fanconi Anemia
ClinicalTrials.gov ID: NCT07901959
What this study is testing
What is Metformin?
An investigational oral medication being studied to help prevent cancer in people with Fanconi anemia.
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 study will see if these common drugs are safe for people with Fanconi anemia and whether they change early signs of cancer in the mouth.
- Who it's for
- The study is looking for adults who have Fanconi anemia.
- What's involved
- Participants will take metformin and naproxen, have regular clinic visits, give small mouth biopsies, and provide oral cell samples with a soft brush for analysis.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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
- Fanconi anemia confirmed by review of past molecular testing (including chromosomal breakage testing results) Age
- Age ≥18 years. Functional Status
- Leukocytes ≥3,000/µL
- Absolute neutrophil count ≥1,000/µL
- Platelets ≥40,000/µL
You likely can't join if
- , Participants will be excluded if any of the following conditions are present: Diabetes-Related Conditions
- Diagnosed diabetes treated with insulin or other anti-diabetic medication
- History of diabetic ketoacidosis
- HbA1c greater than or equal to 6.5%
- Prior use of metformin within the past year Recent Investigational Drug Use
- Receipt of any investigational agents within the past 3 months Drug Hypersensitivity
See the full eligibility criteria
- Fanconi anemia confirmed by review of past molecular testing (including chromosomal breakage testing results) Age
- Age ≥18 years. Functional Status
- Leukocytes ≥3,000/µL
- Absolute neutrophil count ≥1,000/µL
- Platelets ≥40,000/µL
- Total bilirubin ≤1.5 × institutional upper limit of normal (ULN) unless with Gilberts syndrome
- AST (SGOT) / ALT (SGPT) ≤3 × institutional ULN
- eGFR \>45 mL/min (using CKD-EPI equation: https://www.mdcalc.com/ckd-epi-equations-glomerular-filtration-rate-gfr) Viral Infection Status
- HIV-infected patients are eligible if on effective antiretroviral therapy with undetectable viral load within 6 months.
- Chronic HBV infection is permitted if viral load is undetectable on suppressive therapy.
- History of HCV infection is allowed if patient has been treated and cured, or if currently being treated and has undetectable viral load.
- Patients on chronic suppressive antiviral therapy for HSV are eligible. Medication and Intervention Requirements
- Ability to take oral medication. Contraception Agreement
- Willing to use adequate contraception during the study, including: Barrier method, abstinence, vasectomized partner, effective birth control, or postmenopausal status.
- Women of childbearing potential and men must agree to use contraception prior to study entry and throughout participation.
- Female participants who become pregnant or suspect pregnancy must inform the study physician immediately.
- , Participants will be excluded if any of the following conditions are present: Diabetes-Related Conditions
- Diagnosed diabetes treated with insulin or other anti-diabetic medication
- History of diabetic ketoacidosis
- HbA1c greater than or equal to 6.5%
- Prior use of metformin within the past year Recent Investigational Drug Use
- Receipt of any investigational agents within the past 3 months Drug Hypersensitivity
- History of allergic reaction to metformin, naproxen or chemically similar compounds Medical Comorbidities
- Uncontrolled intercurrent illness (e.g., active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, psychiatric/social issues limiting compliance)
- Oral carcinoma in situ on baseline exam or biopsy Pregnancy and Nursing
- Pregnant or breastfeeding women are excluded due to unknown risks of metformin and potential risk of naproxen on the fetus and nursing infant Liver Disease
- Acute or chronic liver disease including elevated liver enzymes \>3x ULN as described above, or diagnosis of infectious or autoimmune hepatitis, cirrhosis, portal hypertension, or hepatocellular carcinoma Active Cancer...
- Current course of chemotherapy, immunotherapy, or radiation for any malignancy (excluding non-melanoma skin cancer or surgically cured organ-confined cancers)
- Prior curatively treated cancers are allowed if treatment is completed within 6 months of study start.
- Ongoing adjuvant hormonal therapy (e.g., for breast cancer) is allowed
- HIV infection is documented and the participant has been on a stable antiretroviral regimen for at least 6 months.
- HIV RNA is below the limit of quantification (e.g., \<50 copies/mL) on the most recent measurement and there is no history of virologic failure within the past 12 months.
- CD4+ T-cell count is ≥200 cells/µL within 6 months prior to enrollment.
- There has been no AIDS-defining illness or active opportunistic infection within the past 12 months.
- The participant's current antiretroviral regimen has no known clinically significant drug-drug interactions with the study intervention.
- NSAID hypersensitivity
- NSAID-induced asthma
- Previous NSAID-induced peptic ulcer
- Other active peptic ulcers
- Renal impairment (eGFR \<45 mL/min)
- Bleeding/clotting disorders (e.g. hemophilia, thrombophilia)
- Current use of systemic (not topical) NSAID or Steroid
- Taking NSAIDs or steroids regularly at time of screening Note: Participants requiring NSAIDs during the trial will be encouraged to use acetaminophen, and can continue in the study as long as the acetaminophen use is...
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
- New York, New York, 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, but 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?
This study is enrolling now at Minneapolis, Minnesota, United States; New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.