{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"120"}]}],"title":"Ribociclib"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1.2"}]}],"title":"Everolumus"}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"}],"units":"Participants"}],"description":"Defined as the highest dose level at which six patients have been treated with at most one patient experiencing a dose limiting toxicity (DLT) and the next higher dose level has been determined to be too toxic. Will be estimated using a Rolling-6 phase I design. Only patients who are evaluable for DLT will be consider for estimating of Maximum Tolerated Dose. Patient who were enrolled under Surgical cohort but received sufficient study defined treatment would also be evaluable for DLT.","groups":[{"description":"Patients either from Phase I stratum and received treatment from beginning, or from Surgical stratum who subsequently received Phase I defined treatment would be evaluable for MTD as long as they received sufficient Phase I defined treatment. Of the patients enrolled in Phase I stratum, 11 of them were evaluable for dose finding assessment. Of the patients enrolled in Surgical stratum, 5 of them were evaluable for dose finding assessment. Therefore, we have total 16 patients evaluable for dose finding assessment, 11 from Phase I stratum and 5 from Surgical stratum.","id":"OG000","title":"DLT Evaluable Set"}],"paramType":"NUMBER","populationDescription":"Patients who were evaluable for dose finding assessment were used to determine the MTD. Evaluable patients are those who were eligible, started treatment and either experienced a dose limiting toxicity during course 1 or received adequate amount of treatment and were followed adequately to be assessed for safety during course 1. Evaluable patients could be from either Phase I stratum or from Surgical stratum as long as they received sufficient protocol defined Phase I treatment.","reportingStatus":"POSTED","timeFrame":"4 weeks","title":"Maximum Tolerated Dose of Ribociclib and Everolimus","type":"PRIMARY","unitOfMeasure":"mg/m^2/day"}