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

Phase 2

Terminated

• Conditions: Kaposi Sarcoma
• Interventions: Drug: everolimus

• Registration Number: NCT01412515
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-08
• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Last Update Submitted: 2011-12-29
• Last Update Posted: 2012-01-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Everolimus	everolimus	everolimus 10 mg per day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
response according to physician global assessment, lesions size , lesions infiltration	30 months	response according to physician global assessment, lesions size , lesions infiltration

Trial Locations

Locations (1)

Hospital Saint Louis; 🇫🇷 Paris, France