Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus (NCT02539459) | Clinical Trial Compass
TerminatedPhase 2
Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus
Stopped: Extreme toxicity, met toxicity stopping rules
United States20 participantsStarted 2015-09-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Absolute neutrophil count \>= 1,500/ microliter (mcL)
* Hemoglobin \>=10 g/dL
* Platelets \>= 100,000/ mcL
* international normalized ratio (INR) \<= 1.2 X Upper limit Normal (ULN)
* activated partial thromboplastin time (aPTT) \<= 1.2 X ULN
* aspartate aminotransferase (AST) / alanine transaminase (ALT) \<= 2.5 X ULN
* Total bilirubin \<= 2.0mg/dL
* Renal Function epidermal growth factor receptor (eGFR) \>= 30 mL/min via calculated creatinine clearance
* Fasting serum cholesterol \<= 300 mg/dL OR \<= 7.75 mmol/L AND fasting triglycerides \<= 2.5x ULN.
Exclusion Criteria:
* History of tuberous sclerosis, LAM or any active malignancy
* Treatment with any other investigational agents for any other disease
* Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding or affect absorption of investigational product
* Active diarrhea of any grade.
* History of human immunodeficiency virus (HIV) infection, hepatitis B or C (screening for all three is mandatory prior to study); prior hepatitis C infection
* Presence of any active or ongoing infection.
* Any known uncontrolled underlying pulmonary disease by history, physical exam or if applicable pulmonary function test (PFTs)…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients With Tumor Volume Reduction Greater Than 25%