RAD001 Therapy of Angiomyolipomata in Patients With TS Complex and Sporadic LAM

Completed · Phase 1/Phase 2

Conditions studied: Tuberous Sclerosis, Lymphangioleiomyomatosis

In brief

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 hypothesis is that the drug will inhibit the growth of the angiomyolipomas and possibly even cause regression.

Key facts

Study ID

NCT00457964

Run by

Children's Hospital Medical Center, Cincinnati

People needed

36

Starts

2005-08-01

Expected to finish

2013-07-01

Last updated by the study team

2013-09-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Pregnant or lactating women
• Continuous requirement for supplemental oxygen
• Surgery within past 2 months
• Use of an investigational drug within last 30 days.

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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