Treatment of Patients With RAD001 With Progressive Sarcoma

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

The purpose of this multicenter, three-arm, exact binomial single-stage, phase II trial is to determine the preliminary efficacy and safety of RAD001 in patients with histological evidence of progressive or metastatic bone or soft tissue sarcoma.

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