Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Feb 17, 2017 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: Everolimus (RAD001); Drug: Everolimus Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Alabama at BirminghamBirmingham, Alabama
- Barrow Tuberous Sclerosis CenterPhoenix, Arizona
- Massachusetts General Hospital Massachussetts General HospitaBoston, Massachusetts
- Minnesota Epilepsy GroupSaint Paul, Minnesota
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- LeBonheur Childrens Medical Group SC-2Memphis, Tennessee
- Novartis Investigative SiteTorono, Ontario
- Novartis Investigative SiteLyon, France
- Novartis Investigative SiteBerlin
- Novartis Investigative SiteMünchen
- Novartis Investigative SiteSiena, SI
- Novartis Investigative SiteTorino, TO
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 17, 2017. Always confirm current availability with the study team.