A Phase II Study With Tumor Molecular Pharmacodynamic (MPD) Evaluation of Oral mTOR-inhibitor Everolimus (RAD001) 10 mg Daily in Patients Suffering From Classic or Endemic Kaposi's Sarcoma

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01412515

Enrollment

Registered

2011-08-09

Start date

2008-06-01

Completion date

2011-05-01

Last updated

2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kaposi Sarcoma

Keywords

mTOR inhibitors

Brief summary

Classic Kaposi's sarcoma (CKS) is an angioproliferation associated with human herpes virus 8 (HHV8), which sometimes requires systemic treatment. Rapamycin and everolimus are mTOR inhibitors. The PI3K-AKT-mTOR pathway is activated in CKS.The aim of this study is to evaluate the rate of clinical response and tolerance to everolimus 10mg/d in CKS. Patients suffering from CKS will be enrolled in a multicenter two-stage phase II trial. At inclusion, all patients will have at least 10 lesions or more than one limb or 3% of body surface affected, in the absence of symptomatic visceral CKS. The primary endpoint is objective response to everolimus after 6 months therapy (complete or partial response per ACTG criteria). The trial is planned using Simon's minimax two-stage design to demonstrate a response rate of 50% as compared to 20% with type I error rate 2.5% and power of 90%. Accordingly, 11 patients will to be enrolled in the first stage and provided at least 3 patients responded, 15 patients will be accrued in a second stage.

Detailed description

The primary endpoint is objective response to everolimus after 6 months therapy (complete or partial response per ACTG criteria). Secondary endpoints are response according to physician global assessment, lesions size , lesions infiltration, lymphedema, tolerance, pharmacodynamic (pathologic, angiogenic and lymphangiogenic biomarkers, HHV8 viral load sequential evaluation in the lesions, pharmacokinetic evaluation.

Interventions

DRUGeverolimus

everolimus per os 10mg per day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Histologic confirmed classic or endemic KS (non transplant non HIV patients) \> 18 Years old at least 10 lesions or more than one limb or 3% of body surface affected, in the absence of symptomatic visceral KS Presence of at least 4 targets lesions \> 5mm At least 4 weeks wash out from any KS specific therapy ECOG \< 2

Exclusion criteria

immunosupressive regimen patients HIV positive creatinine clearance \<40ml/mn,AST ALT\>3N, neutropénia\<1500, thrombopenia\<150000, anemia\<8g/dL

Design outcomes

Primary

Measure	Time frame	Description
objective response to everolimus after 6 months therapy	duration of study 30 months	objective response to everolimus after 6 months therapy (complete or partial response per ACTG criteria).

Secondary

Measure	Time frame	Description
response according to physician global assessment, lesions size , lesions infiltration	30 months	response according to physician global assessment, lesions size , lesions infiltration

Countries

France

Contacts

STUDY_DIRECTORCeleste Lebbé, MD, PhD

Institut National de la Santé Et de la Recherche Médicale, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026