Status:
COMPLETED
RAD001 Therapy of Angiomyolipomata in Patients With TS Complex and Sporadic LAM
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Tuberous Sclerosis
Lymphangioleiomyomatosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this research study is to find out what effects RAD001 has on angiomyolipomas of a person with Tuberous Sclerosis Complex and to determine the safe dose of RAD001 without toxicity. The...
Detailed Description
Tuberous sclerosis complex is a genetic disorder with a birth incidence of approximately one in six thousand. Angiomyolipomas occur in eighty percent of persons with TS, and in up to 60% of persons wi...
Eligibility Criteria
Inclusion
- Diagnosed with angiomyolipomas and have either Tuberous Sclerosis Complex or lymphangioleiomyomatosis
- Angiomyolipoma one centimeter or greater in largest diameter
- Between the ages of 18 and 65 years old.
- If female, documentation of negative pregnancy test prior to enrollment and, where applicable, use of appropriate non-estrogen containing birth control contraceptive regimen while on study.
- Adequate renal function (creatinine \< 3 mg/dl)
Exclusion
- Pregnant or lactating women
- Continuous requirement for supplemental oxygen
- Surgery within past 2 months
- Use of an investigational drug within last 30 days.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00457964
Start Date
August 1 2005
End Date
July 1 2013
Last Update
September 25 2013
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229