Phase 4
Completed N=40
Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex.
Renal Angiomyolipoma
Source: ClinicalTrials.gov NCT03525834 ↗
Enrolled (actual)
40
Serious AEs
15.0%
Results posted
Sep 2021
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 40; 39; 6; 2 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
40; 39; 6; 2 | — |
| SECONDARY Percentage of Participants With Best Overall Response (BOR) Status of Angiomyolipoma (AML) Response During Maximum Treatment Duration of 48 Weeks |
28 | — |
| SECONDARY Percentage of Participants With Best Overall Response Status of Angiomyolipoma (AML) Progression During Maximum Treatment Duration of 48 Weeks |
1 | — |
| SECONDARY Percentage of Participants With Severe Renal Impairment |
0; 1 | — |
| SECONDARY Percentage of Participants With NCI CTCA Grade 3/4 Serum Creatinine |
0; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03525834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.