Clareo Health | Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or Female 18 years or older
Clinically definite diagnosis of Tuberous Sclerosis Complex according to the modified Gomez criteria or sporadic LAM (biopsy-proven or compatible chest CT scan)
Clinically definite diagnosis of renal angiomyolipoma
At least one Angiomyolipoma of ≥ 3 cm in its longest diameter using CT or MRI
Females of child bearing potential must use birth control and have documentation of negative pregnancy test
Written informed consent according to local guidelines
You may not be if
Recent heart attack, cardiac related chest pain or stroke
Severely impaired lung function
Bleeding related to angiomyolipoma or embolization during 6 months prior to randomization
Clinically significant chylous ascites
Clinically significant hematological or hepatic abnormality
Severe liver dysfunction
Severe kidney dysfunction
Pregnancy or breast feeding
Current infection
History of organ transplant
Surgery within two months prior to study enrollment
Prior therapy with a medication in the same class as Everolimus
Recent use of an investigational drug
Bleeding diathesis or on oral anti-vitamin K medication
Uncontrolled high cholesterol
Uncontrolled diabetes
HIV
Inability to attend scheduled clinic visits
Patients with metal implants thus prohibiting MRI evaluations
Angiomyolipoma which requires surgery at the time of randomization
History of malignancy
Severe or uncontrolled medical conditions which would cause an unacceptable safety risk or compromise compliance with the protocol
