Treatment of Patients With RAD001 With Progressive Sarcoma

• Status: Completed
• Trial end date: 2017-05-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Sirolimus

Criteria

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