Treatment of Patients With RAD001 With Progressive Sarcoma

Novartis

Status and phase: Completed; Phase 2

Conditions: Progressive Sarcoma

Treatments: Drug: Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00767819

2007-005294-60 (EudraCT Number)

CRAD001C24114

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 3 patient groups

Arm 1

Experimental group

Description:

Progressive or metastatic bone or soft tissue sarcomas

Treatment:

Drug: Everolimus

Arm 2

Experimental group

Description:

Progressive gastrointestinal stromal tumors (GIST) after failure of prior imatinib and sunitinib 1st and 2nd line

Treatment:

Drug: Everolimus

Arm 3

Experimental group

Description:

Progressive or metastatic alveolar soft part sarcoma (ASPS)

Treatment:

Drug: Everolimus