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 range18 Years
SexALL
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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)…
What they're measuring
1
Number of Patients With Tumor Volume Reduction Greater Than 25%