Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus

(SAGE Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Robert G Uzzo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Fox Chase Cancer Center

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to see if oral everolimus is tolerable and effective in the treatment of sporadic Angiomyolipomas (AMLs). AMLs are the most common non-cancerous tumor of the kidney. They are composed of blood vessels, muscle cells and fat cells.Everolimus is already an approved drug for several other diseases like kidney cancer, but is being studied now specifically to see if it is helpful for people with AML.

Research Team

Robert G Uzzo, MD

Principal Investigator

PI

Eligibility Criteria

Inclusion Criteria

Must have a diagnosis of renal AML > 3 cm confirmed on pre-enrollment Dynamic Contrast Enhanced MRI (DCE-MRI)

Must not have received any prior treatment for AML

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Treatment Details

Interventions

• Everolimus (mTOR inhibitor)

Participant Groups

Group I: Treatment (everolimus) Experimental Treatment 1 Intervention

Patients will take 10 mg (1 tablet) of everolimus each day for 4 months

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Dr. James Helstrom

Fox Chase Cancer Center

Chief Medical Officer since 2014

MD from University of Colorado School of Medicine, MBA from Washington University in St. Louis

Dr. Robert Uzzo

Fox Chase Cancer Center

Chief Executive Officer since 2022

MD from Cleveland Clinic, MBA

Novartis Pharmaceuticals

Industry Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD