RAD001 in Advanced Sarcoma

A Phase II Multicenter Trial of RAD001 in Patients With Metastatic or Recurrent Sarcomas

This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy.

This multicenter, phase II trial evaluated the efficacy and safety of everolimus in patients with metastatic or recurrent bone and soft tissue sarcoma after failure of anthracycline and/or ifosfamide.

Inclusion Criteria:

• Patients with histologically confirmed metastatic, unresectable bone or soft tissue sarcomas who had past treatment with anthracycline and/or ifosfamide to which the disease was primarily refractory or progressed after initial response.
• Any of above drugs is allowed to be used as adjuvant treatment.
• Unidimensionally measurable disease
• 3 or less than prior chemotherapies
• Age 17 years old or older
• ECOG performance status 2 or less, Life expectancy 6 month or less
• Adequate bone marrow, liver, kidney, and cardiac function
• Written informed consent

Exclusion Criteria:

• Pregnant or lactating patients
• Patients with resectable metastasis
• Patients with history of CNS metastasis
• Gastrointestinal stromal tumors, chondrosarcoma, neuroblastoma
• Hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients.
• Any preexisting medical condition of sufficient severity to prevent full compliance with the study