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

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.

Timeline

Start

2008-06

Primary completion

2011-05

Completion

2011-05

Outcome

Outcome not reported

Stopped: “results from interim analysis conducted to study interruption”

Publications

• Results Mourah S, Porcher R, Battistella M, Kerob D, Guillot B, Jouary T, Agbalika F, Morinet F, Furlan V, Teisserenc HM, Dupin N, Lebbe C. Paradoxical simultaneous regression and progression of lesions in a phase II study of everolimus in classic Kaposi sarcoma. Br J Dermatol. 2015 Nov;173(5):1284-7. doi: 10.1111/bjd.13897. Epub 2015 Aug 19. No abstract available.

Drugs

Indications