Clinical trial · Interventional
A Phase IV Study of Safety and Efficacy of Everolimus in Taiwanese Patients With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma (TSC-AML)
Phase IV, Prospective Single Arm Study of Safety and Efficacy of Votubia (Everolimus) in Taiwanese Adults With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma
NCT05252585CI-TRIAL-00114355active not recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
The purpose of this prospective study is to assess the safety and efficacy of everolimus in Taiwanese patients with renal angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC) . Only patients who fulfil the local reimbursement criteria of everolimus for TSC-AML will be included in this study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Angiomyolipoma | Kidney Angiomyolipoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Everolimus
- description
- Participants with confirmed diagnosis of TSC-AML and who fulfil the local (Taiwan) reimbursement criteria of everolimus for TSC-AML treatment
- interventionNames
- Drug: Everolimus
Primary outcomes (1)
- measure
- Percentage of participants with adverse events (AEs), Serious AEs (SAEs) and AEs of special interest (AESI)
- timeFrame
- From first dose of study treatment up to 56 weeks
- description
- Percentage of participants with AEs, SAEs and AESIs.
Secondary outcomes (3)
- measure
- Angiomyolipoma (AML) response rate
- timeFrame
- Up to 52 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult male or female patients from ≥ 18 years of age. 2. Signed informed consent must be obtained prior to participation in the study. 3. Participants with TSC associated with renal AML which is eligible for treatment with everolimus per local reimbursement criteria. Exclusion Criteria: 1. Patients with severe hepatic impairment (Child-Pugh class C) 2. Any severe and/or uncontrolled medical conditions. 3. Pregnant or breast-feeding females. 4. Patients with hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients.
References
Publications (0)
Data not yet available
No reference posted for this study.