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Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex.

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Novartis

Status and phase

Completed
Phase 4

Conditions

Renal Angiomyolipoma

Treatments

Drug: Everolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT03525834
CRAD001M2401

Details and patient eligibility

About

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).

Full description

This was an open label, single arm, multi-center, Phase IV Post-Approval Commitment (PAC) study with once daily oral dose of 10 mg everolimus in participants with renal AML associated with TSC. There were three separate phases in this study: a Screening phase, an Open-label treatment phase where participants received everolimus for 48 weeks or until disease progression, and a Treatment discontinuation follow-up phase for patients who discontinue study drug for reasons other than disease progression. Every participant had an End of Treatment visit within 28 days after last dose and a safety follow-up visit 30 days after last dose.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Everolimus
Experimental group
Description:
Participants targeted to receive Everolimus tablets 10 mg orally once daily for 48 weeks.
Treatment:
Drug: Everolimus

Trial documents
2

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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