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NCT01981525 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study of Metformin in Patients With a Diagnosis of Li-Fraumeni Syndrome
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01981525: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01981525 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01981525, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Background: * Li Fraumeni Syndrome (LFS) is a highly penetrant, autosomal dominant cancer predisposition disorder. Four main cancer types including sarcoma, adrenocortical carcinoma, breast cancer, and malignant brain tumors commonly characterize LFS but the syndrome can include other cancers. * Metformin is an oral biguanide drug that is approved by the FDA for the treatment of type II diabetes. Metformin has been associated with reduced cancer risk in several epidemiologic studies and reduced cancer mortality in patients with type 2 diabetes. * Metformin decreases circulating insulin and IGF1, and promotes glucose uptake in skeletal muscle and inhibits gluconeogenesis in the liver. Elevations in circulating insulin and IGF1 levels have been associated with increased cancer risk. * Preclinical research in animal models shows that metformin may be more toxic in cancer cells that have lost p53 function. * Lifetime risk of cancer in LFS patients with germline TP53 mutations is estimated to be up to 70% by age 60, with women having excess lifetime cancer risk (up to 100%) compared to men (up to 80%). There are currently no approved chemopreventive agents for patients with LFS. * Metformin has been shown to be safe and tolerable in diabetic and non-diabetics, and may be an ideal candidate for chemoprevention of cancer in this population. Objectives: * Determine the tolerability of oral daily metformin in patients with LFS caused by germline TP53 mutations. * Determine if 8 weeks of daily metformin administration has any effect on circulating IGF-1, insulin, and IGFBP3 Eligibility: * Must have a germline TP53 mutation and provide documentation of testing. * Must have adequate organ function. * Age greater than or equal to 18 years. Design: * This is a pilot study to assess the tolerability of daily oral metformin administration in patients with LFS caused by germline TP53 mutations and to study the effect of metformin on biomarker levels in these subjects. * In th
Interventions
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2014-01-27 |
| Est. Completion | 2020-12-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01981525
The ClinicalTrials.gov registry entry for NCT01981525 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Metformin is the first listed.
NCT01981525 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01981525 about?
NCT01981525 is a clinical study titled "A Pilot Study of Metformin in Patients With a Diagnosis of Li-Fraumeni Syndrome". Background: * Li Fraumeni Syndrome (LFS) is a highly penetrant, autosomal dominant cancer predisposition disorder. Four main cancer types including sarcoma, adrenocortical carcinoma, breast cancer, and malignant brain tumors commonly characterize LFS but the syndrome can include other cancers. * Me...
What is the current status of trial NCT01981525?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2014-01-27. Estimated completion is 2020-12-11.
What interventions are being tested in trial NCT01981525?
The interventions under investigation include: Metformin (DRUG).
Who is sponsoring clinical trial NCT01981525?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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