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
Inclusion Criteria:
Histological evidence of progressive or metastatic bone or soft tissue sarcoma.
The following tumor types are included:
- malignant fibrous histiocytoma
- liposarcoma
- synovial sarcoma
- malignant paraganglioma
- fibrosarcoma
- leiomyosarcoma
- angiosarcoma including haemangiopericytoma
- malignant peripheral nerve sheath tumor
- STS, not otherwise specified
- miscellaneous sarcoma including mixed mesodermal tumors of the uterus
- osteosarcoma
- Ewing's sarcoma
- rhabdomyosarcoma
- gastrointestinal stromal tumor (only after failure or intolerance of imatinib or
sunitinib in 1st and 2nd line)
- alveolar soft part sarcoma (ASPS)
- Objective progression of disease may be documented by RECIST criteria. Any of
the following would be sufficient according to RECIST:
- a 20% increase in the sum of unidimensionally measured target lesions
- a new lesion
- unequivocal increase in non-measurable disease.
- Patients must have disease not amenable to surgery, radiation, or combined
modality therapy with curative intent.
- ECOG performance status 0 - 2.
Exclusion Criteria:
Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy,
immunotherapy, or radiotherapy.
- The following tumor types will not be included:
- gastrointestinal stromal tumor (except for patients after treatment with
imatinib or sunitinib in 1st and 2nd line)
- chondrosarcoma
- malignant mesothelioma
- neuroblastoma.
- Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).
- Neurotoxicity > grade 2 CTC.
- Radiation of the lung.
Other protocol-defined inclusion/exclusion criteria may apply