Clinical trial · Interventional
RAD001 Therapy of Angiomyolipomata in Patients With TS Complex and Sporadic LAM
RAD001 Therapy of Angiomyolipomata in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis
NCT00457964CI-TRIAL-00012275completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphangioleiomyomatosis | Lymphangioleiomyomatosis | ONTOLOGY_EXACT | 0.98 |
| Tuberous Sclerosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAD001 | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Administration of RAD001
- interventionNames
- Drug: RAD001
Primary outcomes (1)
- measure
- Patients will be considered responders if their angiomyolipoma volume decreases by thirty percent or more from baseline
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * Pregnant or lactating women * Continuous requirement for supplemental oxygen * Surgery within past 2 months * Use of an investigational drug within last 30 days.
References
Publications (0)
Data not yet available
No reference posted for this study.