Status:
COMPLETED
Treatment of Patients With RAD001 With Progressive Sarcoma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Progressive Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 progress...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2017
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00767819
Start Date
March 31 2008
End Date
May 17 2017
Last Update
April 1 2019
Active Locations (6)
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1
Novartis Investigative Site
Bad Saarow, Germany, 15526
2
Novartis Investigative Site
Düsseldorf, Germany, 40479
3
Novartis Investigative Site
Essen, Germany, 45147
4
Novartis Investigative Site
Mannheim, Germany, 68167