Clinical trial · Interventional
Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex.
Phase IV, Single Arm Study of Safety and Efficacy of Everolimus in Chinese Adults With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma Not Requiring Immediate Surgery
NCT03525834CI-TRIAL-00053786completedPhase 4Results postedClinicalTrials.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 study was to assess the safety and efficacy of everolimus (Afinitor®) in Chinese patients with renal angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC).
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 targeted to receive Everolimus tablets 10 mg orally once daily for 48 weeks.
- interventionNames
- Drug: Everolimus
Primary outcomes (1)
- measure
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- timeFrame
- From the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 52 weeks
- description
- Percentage of participants with AEs and SAEs including significant changes from baseline in vital signs, electrocardiograms and laboratory parameters (laboratory assessments included hematology, biochemistry, coagulation and urinalysis) qualifying and reported as AEs. The percentage of participants in each category is reported in the table.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible for treatment with everolimus as per the locally approved label. * Presence of at least one AML ≥ 3 cm in its longest diameter using CT or MRI. Exclusion Criteria: * AML related bleeding or embolization during the 6 months prior to enrollment. * History of myocardial infarction, angina or stroke related to atherosclerosis. * Impaired lung function. * Significant hematological or hepatic abnormality. * Any severe and/or uncontrolled medical conditions.
References
Publications (0)
Data not yet available
No reference posted for this study.