Safety and efficacy of BEZ235 in patients with perivascular epithelioid cell tumors (PEComas)
- Conditions
- Adult patient with metastatic or unresectable malignant perivascular epithelioid cell tumors (PEComa)MedDRA version: 14.1Level: PTClassification code 10039491Term: SarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001884-39-NL
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 33
Histologically confirmed diagnosis of malignant PEComa (included epithelioid angiomyolipoma (AML)) in adult patients
Unresectable/advanced and/or metatstatic and documented progressive measurable disease
Treated with 1 or 2 prior lines of treatment
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 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16
Disease exclusions : lymphangioleiomyomatosis (LAM) exclusively, active uncontrolled or symptomatic CNS metastases, concurrent malignancy or malignancy in last 3 years
Concurrent severe and/or uncontrolled medical conditions (for details see protocol)
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method