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-IT
- Lead Sponsor
- OVARTIS FARMA
- 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. Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
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 exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the efficacy of BEZ235 in PEComa patients;Secondary Objective: To determine the PFS rate at 32 weeks in the included population; To assess the duration of response among responders; To evaluate time to response; To evaluate the time to progression; To assess the overall survival; To evaluate safety and tolerability of BEZ235.;Primary end point(s): Objective Response Rate (best response on study) according to RECIST 1.1 criteria;Timepoint(s) of evaluation of this end point: 32 weeks after the last enrolled patient
- Secondary Outcome Measures
Name Time Method Secondary end point(s): PFS rate at 32 weeks of follow-up; Duration of response using with RECIST 1.1 criteria; Time to response; Time to progression; Overall survival; Frequency and severity of adverse events and laboratory values abnormalities; Other safety data as considered appropriate.;Timepoint(s) of evaluation of this end point: 32 weeks after the last enrolled patient