NCT02539459

Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus

A Phase II Study of Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Primary Objective 1\. To evaluate the efficacy and tolerability of everolimus in reducing tumor volume in sporadic AMLs as measured by dynamic contrast enhanced magnetic resonance imaging (DCE MRI), in patients who might otherwise be considered for active surgical or percutaneous intervention. Secondary Objectives 1. To evaluate health-related quality of life (HRQoL) in subjects treated with everolimus for sporadic AMLs. 2. To assess the growth kinetics of sporadic AMLs in patients who have been treated with everolimus as part of the study and demonstrate an objective response as well as those who have been treated with everolimus during the study with a suboptimal or no response. 3. To measure the rate of surgical or percutaneous (embolization) intervention at 1 year from day 1 of study. 4. To assess the safety and tolerability of everolimus in patients with sporadic AML.

Conditions

• Sporadic Angiomyolipomas (AMLs)

Interventions

Type	Name	Description
DRUG	Everolimus	10 mg tablets

Timeline

• Start date: 2015-09-23
• Primary completion: 2018-08-20
• Completion: 2018-08-20
• First posted: 2015-09-03
• Last updated: 2022-12-15
• Results posted: 2021-02-17

Locations

8 sites across 1 country: United States