RAD001 in Advanced Sarcoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: Novartis
• Treatments: Everolimus; Sirolimus

Criteria

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