ActivePhase 1ACTRN12612000136808

Phase I study of RAD001 (Everolimus) in combination with Fluvastatin and Zoledronic acid in patients with solid tumours

A study of the safety and toxicity of the combination of zoledronic acid, fluvastatin and everolimus given to patients with advanced cancer


Sponsor

St George Hospital

Enrollment

25 participants

Start Date

Aug 20, 2008

Study Type

Interventional

Conditions

Summary

This study aims to investigate whether the combination of everolimus (RAD001), fluvastatin, and zoledronic acid can be given safely together and to determine the toxicities, if any, of the combination. Who is it for? You may be eligible for this study if you have advanced cancer which has continued to grow despite the use of other therapies. Trial Details In this trial, you will receive an combined treatment of the drugs Everolimus escalating from 2.5mg to 10mg daily, fluvastatin 80mg to 120mg daily, and zoledronic acid 4mg intravenously every 3 weeks until either you experience intolerable side effects or until your cancer grows again. We hope that the combination treatment will ultimately not only be fairly well tolerated, but act synergistically to help slow down the rate of tumour growth.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This Phase I study tests the combination of everolimus (RAD001), fluvastatin, and zoledronic acid in adults with advanced solid tumours that have no curative treatment options. Participants must be 18 or older with adequate organ function and a life expectancy of at least 12 weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Everolimus 2.5mg (dose level 1) to 5mg (dose level 2) to 10mg daily (dose level 3), fluvastatin 80mg (dose levels 1 &2) to 120mg daily (dose level 3) , and zoledronic acid 4mg (fixed dose) intravenous

Everolimus 2.5mg (dose level 1) to 5mg (dose level 2) to 10mg daily (dose level 3), fluvastatin 80mg (dose levels 1 &2) to 120mg daily (dose level 3) , and zoledronic acid 4mg (fixed dose) intravenously every 3 weeks. After recruitment for each dose level has been completed (no set time), toxicity will be assessed for that dose level before patients are enrolled onto the next dose level. Endpoint depends on toxicity during the first cycle.


Locations(1)

NSW, Australia

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