{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"100"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"}],"description":"Maximum tolerated dose (MTD) is defined as the dose level preceding the dose in which greater than or equal to 2 out of 3-6 patients experience a dose limiting toxicity (DLT) assessed using CTCAE v4","groups":[{"description":"Patients receive PI3K inhibitor BKM120 PO QD 100 mg/day on days -7 to 0. Patients complete 1 week washout. After dose escalation phase, 3 patients receive BKM120 PO 80mg / day and cetuximab 500 mg IV /14 days and 9 patients receive BKM120 PO 100mg / day and cetuximab 500 mg IV /14 days thereafter.\n\nAll patients receive PI3K inhibitor BKM120 PO QD day on days 1-28 and cetuximab IV over 60-120 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nPI3K inhibitor BKM120: Given PO\n\ncetuximab: Given IV","id":"OG000","title":"Arm I (BKM120 PO and Cetuximab 500 mg IV 14 Days)"}],"paramType":"NUMBER","populationDescription":"0 patients out of 3 from the BKM 80mg/day cohort had DLT (dose limiting toxicities). 0 patients out of 9 from the BKM 100mg/day cohort had DLT.","reportingStatus":"POSTED","timeFrame":"28 days","title":"Maximum Tolerated Dose (MTD)","type":"PRIMARY","unitOfMeasure":"mg / day"}