{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"75"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"}],"units":"Participants"}],"description":"Rolling-6 design was used to estimate MTD. The MTD was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a DLT and the next higher dose level had been determined to be too toxic. Stratum II consisted of heavily pre-treated patients.","groups":[{"description":"Of 14 patients enrolled on stratum II, 3 patients were not evaluable for dose finding assessment: 2 patients due to receiving less than required dose of study drug and 1 due to withdrawal consent prior to beginning protocol therapy. The remaining 11 patients were used to determine the MTD for stratum II.","id":"OG000","title":"Stratum II"}],"paramType":"NUMBER","populationDescription":"Patients who were enrolled on stratum II and were evaluable for dose finding assessment were used to determine the MTD for stratum II.","reportingStatus":"POSTED","timeFrame":"4 weeks","title":"Maximum Tolerated Dose (MTD) of Palbociclib in Stratum II","type":"PRIMARY","unitOfMeasure":"mg/m2/day"}