{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"title":"P13K Positive - Responder"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"P13K Positive - Non-Responder"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"1"}]}],"title":"P13K Negative - Responder"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}],"title":"P13K Negative - Non-Responder"}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"4"}],"units":"Participants"}],"description":"Phosphoinositide 3-kinase (PI3K) biomarker status, either positive or negative, analyzed using established methods from tumor biopsies. P13K status is reported by response, either responder (CR or PR) or non-responder (SD or PR).","groups":[{"description":"* 40 mg BKM120 will be administered orally daily for 45 days. Starting dose 40 mg.\n* Cisplatin: Starting Dose 30 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).\n* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.\n\nBKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.\n\nCisplatin: Cisplatin is a chemotherapy drug\n\nIntensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells","id":"OG000","title":"Dose Level 1"},{"description":"* 40 mg BKM120 will be administered orally daily for 45 days.\n* Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).\n* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.\n\nBKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.\n\nCisplatin: Cisplatin is a chemotherapy drug\n\nIntensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells","id":"OG001","title":"Dose Level 2"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Biomarker data was not collected for all patients. Data reported for all patients who were biopsied.","reportingStatus":"POSTED","timeFrame":"Biopsies drawn up to 10 days from registration. Response measured at from baseline to cycle 9, up to 66 days.","title":"P13K Status by Response","type":"SECONDARY","unitOfMeasure":"Participants"}