Trial · NCT07901959
Safety and Tolerability of Metformin and Naproxen for Cancer Prevention in Fanconi Anemia
NCT07901959, Phase 1, Recruiting, Rockefeller University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of Metformin and Naproxen for Cancer Prevention in Fanconi Anemia. Trials, record NCT07901959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07901959
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of Metformin and Naproxen for Cancer Prevention in Fanconi Anemia
- NCT number
- NCT07901959
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 80 participants, estimated
- Lead sponsor
- Rockefeller University
- Conditions
- Fanconi Anemia, Head and Neck Cancer, Squamous Cell Carcinoma, Squamous Cell Cancer of Head and Neck (SCCHN)
- Interventions
- Metformin, Naproxen Sodium
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety | For the duration of the study, 22 months for each individual participant | The investigators will assess the primary outcome of safety and tolerability of metformin and naproxen as chemoprevention agents for head and neck squamous cell carcinoma in Fanconi anemia patients: Incidence of Grade 2 or Higher Intervention-Related Adverse Events (AEs) Description: The number and percentage of participants experiencing at least one grade ≥2 AE judged to be related to study intervention (as per CTCAE v5.0 criteria). Investigators will compare the proportion of adverse events for pre-intervention vs. metformin and pre-intervention vs. naproxen. Time Frame: Throughout the drug intervention period and up to 30 days after last intervention dose. Assessment Methods: Investigator assessment at clinic visits, participant self-reports, and clinical laboratory evaluations. Safety Goal: \<5% of participants experiencing Grade ≥3 drug-related AEs. |
| Primary | Tolerability of Intervention Regimen | Duration of intervention, from month 3 to month 16 of the study for each participant. | Defined as participant retention and ability to continue intervention without dose-limiting toxicities, treatment discontinuation, or withdrawal due to side effects. Investigators will report proportion of dropout during each intervention. |
| Secondary | Frequency of Any Adverse Events (All Grades) | Baseline visit through end of study, a weekly survey will assess AEs. Participants can report AEs to designated study staff at any point during the duration of the study, | Count and categorization of all reported AEs, regardless of severity or attribution. The investigators will report proportion of participant with AEs attributed to drug, subcategorized by intervention during which AE occurred and AE grade. |
| Secondary | Adherence to Intervention Regimen (Pill Counts and participant report) | Pill counts will occur at the 9 month and 16 month site visits. Participant adherence self-report surveys will be collected at the 9 month and 16 month site visits. | Proportion of prescribed doses taken, measured via pill count and participant report via survey checklist. |
| Secondary | Self-Reported Adherence and Symptom Tracking | Weekly for the duration of the study. | Participant-reported adherence, side effects, and symptoms logged weekly through electronic survey tools. |
| Secondary | Self-Exam Completion Rate (via FAexam App) | Monthly for the duration of the study. | Proportion of expected monthly oral exams completed by participants using the secure FAexam app. |
| Secondary | New oral lesions | At each site visit (baseline, 3 month, 9 month, 16 month and 22 month) for the duration of the study. | The investigators will record and compare the change in lesion number and size for participants between the start and end of the intervention period compared to between the start and end of the preintervention period. Assessment methods: Lesion status will be assessed at each study visit through oral examination, lesion mapping and measurement, and standardized, non-identifying oral cavity imaging. Comparisons will be made between pre-intervention vs after metformin, and between preintervention vs after naproxen. The investigators will compare the mean number of lesions in each time period across intervention groups. |
| Secondary | Target Lesion Histological Grade | At each site visit (baseline, 3 month, 9 month, 16 month and 22 month) for the duration of the study. | Histological grading (e.g., normal, hyperplasia, dysplasia, carcinoma in situ) from a target lesion selected based on clinical features at: 1. end of pre-intervention period (3-month visit) and compared to follow up biopsy at end of first intervention period (9-months). 2. end of first intervention period (9-month visit) will be compared to subsequent follow up biopsy at end of second intervention period (16-months). 3. end of second intervention period (16-month visit) will be compared to subsequent follow up biopsy at end of study (22-months). Histologic changes in that lesion will be evaluated by a trained pathologist and used to assess response to intervention. The investigators will compare the mean number of lesions in each grade category in each time period across intervention groups. |
| Other | Presence of Pathogenic TP53 Variants (Oral Brush Samples) (Exploratory) | Brush samples will be collected at each site visit (baseline, 3 month, 9 month, 16 month and 22 month) for the duration of the study. | Binary variable (presence/absence) indicating whether pathogenic or likely pathogenic somatic TP53 variants are detected in oral brush samples. Somatic origin will be deduced by presence of the same variant in all tested oral sites and if necessary, confirmed by comparing results to matched germline DNA (blood or skin). The presence of TP53 variants will be tracked longitudinally and compared across timepoints pre- and post-intervention. |
| Other | Presence of Copy Number Variants (CNVs) in Oral Brush Samples (Exploratory) | Brush samples will be collected at each site visit (baseline, 3 month, 9 month, 16 month and 22 month) for the duration of the study. | Binary variable indicating detection of CNVs via genome-wide SNP genotyping. The presence of CNVs will be tracked longitudinally and compared across timepoints pre- and post-intervention. Brushing will be performed at each study visit. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers16
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07901959
GET https://conductscience.org/api/trials/v1/NCT07901959/registered