{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Stable Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Progression of Disease"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"}],"units":"Participants"}],"description":"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR","groups":[{"description":"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.\n\neverolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity","id":"OG000","title":"Patients Getting Everolimus"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"16 weeks","title":"To Determine the Rate of Clinical Benefit (i.e. Rate of Complete or Partial Response Plus Stable Disease) at 16 Weeks for Patients With Malignant Mesothelioma Treated With Everolimus as Second or Third Line Therapy.","type":"PRIMARY","unitOfMeasure":"participants"}