Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-02-24 @ 5:46 AM
Study NCT ID:
NCT02539459
Status:
TERMINATED
Last Update Posted:
2022-12-15
First Post:
2015-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus
Sponsor:
Fox Chase Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Study of Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus Therapy
Status:
TERMINATED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Extreme toxicity, met toxicity stopping rules
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAGE
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: