Status:
TERMINATED
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
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Kaposi Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 assess...
Eligibility Criteria
Inclusion
- 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
- immunosupressive regimen patients HIV positive creatinine clearance \<40ml/mn,AST ALT\>3N, neutropénia\<1500, thrombopenia\<150000, anemia\<8g/dL
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01412515
Start Date
June 1 2008
End Date
May 1 2011
Last Update
January 2 2012
Active Locations (1)
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1
Hospital Saint Louis
Paris, France, 75010