ISRCTN16699730进行中（未招募）2 期
Metformin in Li Fraumeni Syndrome (MILI) Trial: A phase II randomised open-label cancer prevention trial of metformin in adults with Li Fraumeni Syndrome
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 224
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38308321/ (added 09/02/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of LFS from confirmed pathogenic TP53 variant (class IV or V by CanVIG-UK criteria
- •2. Aged >16 years
- •3. Capable of understanding the consent process and participating in the study (including proving blood samples), in the investigators’ decision
排除标准
- •1. Currently taking metformin
- •2. Metformin intake for more than 3 months in total, within the 2 years antecedent to the date of trial enrolment
- •3. Completion of cancer systemic therapy within the 6 months antecedent to the date of trial enrolment
- •4. Current type 1 or 2 diabetes mellitus
- •5. Presence of ongoing active cancer (detected previously or at baseline scanning)
- •6. Current pregnancy or lactation
- •7. Gastro-intestinal condition (such as short-bowel syndrome) that could affect uptake of metformin
- •8. Concurrent illness (other than LFS) that could result in life expectancy of <5 years
- •9. History of the following cardiac conditions:
- •9.1. Congestive cardiac failure of >Grade II severity according to the New York Heart Association Functional Classification (defined as symptomatic at less than ordinary levels of activity).
- •9.2. Ischaemic cardiac event including myocardial infarction within 3 months prior to date of enrolment.
- •9.3. Uncontrolled cardiac disease,including unstable angina pectoris,uncontrolled hypertension (i.e.,sustained systolic BP >160 mmHg or diastolic BP >90 mm Hg)
- •10. Evidence of significant renal impairment eGFR <50ml50ml/minute/1.73m² (those with eGFR between 50-60ml/minute/1.73m² are eligible to enter but, if in the metformin arm, will undergo modified dose-titration)
- •11. Liver cirrhosis and/or alkaline phosphatase,aspartate transaminase or alanine transaminase >2.5 x upper limit of normal (ULN)
- •12. Elevated risk of lactic acidosis such as current chronic alcoholism,congenital lactic acidosis,concurrent intake of carbonic anhydrase inhibitor (e.g. acetazolamide)
- •13. Known allergy to metformin
- •14. Does not fulfil MRI Safety Screening criteria (e.g. implanted cardiac pacemaker, post-surgical metal hardware – plates etc) and/or unable to undergo baseline scan.
研究者
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