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-HU

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 33

Inclusion Criteria

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Disease exclusions : lymphangioleiomyomatosis (LAM) exclusively, ative 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

;
Disease exclusions : lymphangioleiomyomatosis (LAM) exclusively, ative 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