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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
18 Years
N/A
Not Enrolling
Both
Kaposi Sarcoma

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

objective response to everolimus after 6 months therapy

Outcome Description:

objective response to everolimus after 6 months therapy (complete or partial response per ACTG criteria).

Outcome Time Frame:

duration of study 30 months

Safety Issue:

No

Principal Investigator

Celeste Lebbé, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

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

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

C06-46

NCT ID:

NCT01412515

Start Date:

June 2008

Completion Date:

May 2011

Related Keywords:

  • Kaposi Sarcoma
  • mTOR inhibitors
  • Sarcoma, Kaposi
  • Stress, Psychological
  • Sarcoma

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