Multicenter, single-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 - ND

• Conditions: progressive or metastatic bone or soft tissue sarcomas; MedDRA version: 9.1Level: LLTClassification code 10006007Term: Bone sarcoma

• Registration Number: EUCTR2007-005294-60-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-26
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

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. 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. PLS see protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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;  chondrosarcoma;  malignant mesothelioma;  neuroblastoma.  Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).  neurotoxicity ≥ grade 2 CTC.  Radiation of the lung.  Patients taking drugs known to inhibit or induce isoenzyme CYP3A (Table 6-4) are excluded unless the drugs are medically necessary and no substitutes are available. If there are no acceptable substitutes, special precautions should be taken in these patients (section 6.3.5).  Patients with any concurrent major medical condition liable to compromise the patient`s participation in the study (e.g. known HIV infection, uncontrolled diabetes, serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure, myocardial infarction within 6 months, unstable angina, chronic or acute renal or liver disease, uncontrolled serious infections including abscess or fistulae, etc.).  Patients with a history of another malignancy prior to study entry, except curatively treated non-melanotic skin cancer or carcinoma in-situ cervical cancer unless in complete remission or no evidence of disease and off all therapy for that disease for a minimum of 5 years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified