Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01981525 : A Pilot Study of Metformin in Patients With a Diagnosis of Li-Fraumeni Syndrome
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
- INCLUSION CRITERIA:

- All TP53 germline mutation positive adult patients will be eligible for this study.
All patients must have a documented TP53 germline mutation.

- Patients with history of cancer must be in remission, with surgery completed at least
6 months prior to enrollment and chemotherapy completed at least 1 year prior to
enrollment (except for basel cell carcinoma of the skin).

- Age greater than or equal to 18 years. The doses of metformin used in this study
exceed the maximum recommended daily dose for the pediatric population.

GENERAL EXCLUSION CRITERIA:

- Patients who have had stem-cell transplantation.

- Current use of metformin or other anti-diabetic agents, or hypersensitivity or
allergy to metformin.

- Patients who are receiving any other investigational agents.

- Patients with history of chronic alcohol use

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to metformin or other agents used in study.

- Patients with congestive heart failure requiring pharmacological management.

- Uncontrolled inter-current illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01981525      |      Link to official Clinicaltrials.gov listing
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