{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"}]}],"title":"Complete Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"}]}],"title":"Partial Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"Stable Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]}],"title":"Progressive Disease"}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"The best overall response for each patient is given per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) criteria:\n\nComplete Response (CR) - Disappearance of all target and non-target lesions and lymph node short axis is \\<10 mm and no new lesions\n\nPartial Response (PR)\n\n* Disappearance of target lesions and \\>=1 persisting non-target lesion or tumor marker levels above normal limits and no new lesions or\n* \\>=30% decrease in sum of target lesion diameter and no new lesions\n\nStable Disease (SD)\n\n\\- Less than 5 mm increase in target lesion diameter unless it results in a \\>=20% increase in diameter and \\>=1 persisting non-target lesion or tumor marker levels above normal limits and no new lesions\n\nProgressive Disease (PD)\n\n* \\>20% increase in target lesion diameter, must be an absolute increase of 5mm or\n* Substantial worsening in non-target lesion or\n* New lesion present","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","reportingStatus":"POSTED","timeFrame":"Measured at end of treatment, up to 66 days","title":"Best Overall Response","type":"SECONDARY","unitOfMeasure":"Participants"}