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
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
objective response to everolimus after 6 months therapy
objective response to everolimus after 6 months therapy (complete or partial response per ACTG criteria).
duration of study 30 months
No
Celeste Lebbé, MD, PhD
Study Director
Institut National de la Santé Et de la Recherche Médicale, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
C06-46
NCT01412515
June 2008
May 2011
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