A Pilot Study of Metformin in Patients With a Diagnosis of Li-Fraumeni Syndrome

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

January 27, 2014

Primary Completion Date

June 30, 2016

Study Completion Date

December 11, 2020

Conditions
Li-Fraumeni Syndrome
Interventions
DRUG

Metformin

Treatment will be administered primarily on an outpatient basis. Patients will be instructed to take 500 mg metformin by mouth 1, 2 or 3 times a day or 1000 mg twice per day depending on dose level. Patients will receive metformin at level 1 dose for 2 weeks. If dose is tolerated, patient will receive level 2 dose for 2 weeks and if tolerated will escalate to level 3 dose, and if tolerated will escalate to level 4 dose. Metformin will be taken for 14 weeks.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT01981525 - A Pilot Study of Metformin in Patients With a Diagnosis of Li-Fraumeni Syndrome | Biotech Hunter | Biotech Hunter