EUCTR2007-000974-22-FR
Active, not recruiting
Not Applicable
Essai thérapeutique de phase II séquentiel non randomisé non contrôlé, multicentrique de traitement par everolimus de la maladie de Kaposi classique ou endémique. - Rad Kaposi
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Maladie de Kaposi classique ou endémique
- Sponsor
- Inserm
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Age \> 18 ans
- •\-Maladie de kaposi classique ou endémique confirmée histologiquement
- •\-Plus de 10 lésions ou plus d’un membre atteint, ou atteinte de plus de 3% de la surface corporelle
- •\-Absence d’atteinte viscérale symptomatique
- •\-Délai d’au moins 4 semaines avec le dernier traitement spécifique de la maladie de kaposi
- •\-OMS 0 ou 1
- •\-ECOG \< 2 (cf annexe 18\.16\)
- •\-Présence d’au moins 4 lésions cutanées de plus grand diamètre supérieur ou égal à 5 mm (lésions cibles)
- •\-Espérance de vie \> 12 mois
- •\-BH : bilirubine totale \< 25umol/l, transaminases \< 3N
Exclusion Criteria
- •\-Moins de 4 lésions mesurables (taille\<5mm)
- •\-Sérologie VIH, hépatite B ou C positive
- •\-Maladie infectieuse évolutive
- •\-Pathologie tumorale évolutive nécessitant un traitement spécifique
- •\-Pathologie auto\-immune évolutive
- •\-Pathologie pulmonaire évolutive
- •\-Grossesse ou allaitement
- •\-Absence de signature du consentement ou refus du patient
- •\-Hypersensibilité à l’everolimus (RAD001\), au sirolimus au à ses excipients
- •\-Traitement par :
Outcomes
Primary Outcomes
Not specified
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