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|NCT01981525 : A Pilot Study of Metformin in Patients With a Diagnosis of Li-Fraumeni Syndrome|
|Ages||Min: 18 Years Max: N/A|
- 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
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01981525
| Link to official Clinicaltrials.gov listing