Multicenter, triple-arm, single-stage, phase II trial to determine the preliminary efficacy and safety of RAD001 in patients with histological evidence of progressive or metastatic bone or soft tissue...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-005294-60

Multicenter, triple-arm, single-stage, phase II trial to determine the preliminary efficacy and safety of RAD001 in patients with histological evidence of progressive or metastatic bone or soft tissue sarcomas

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Extrait

To evaluate preliminary efficacy of RAD001 in progressive or metastatic alveolar soft part sarcoma (ASPS). Efficacy is defined as the proportion of patients showing complete response, partial response or stable disease at 16 weeks. To evaluate preliminary efficacy of RAD001 in patients with gastorintestinal stromal tumor (GIST) after failure or intolerance of treatment with imatinib or sunitinib in 1st or 2nd line. Efficacy is defined as the proportion of patients showing complete response, partial response or stable disease at 16 weeks.


Critère d'inclusion

  • histological evidence of progressive or metastatic bone or soft tissue sarcomas