{"classes":[{"categories":[{"measurements":[{"comment":"Final conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.","groupId":"OG000","value":"NA"},{"comment":"Final conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.","groupId":"OG001","value":"NA"},{"comment":"Final conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.","groupId":"OG002","value":"NA"},{"comment":"Final conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.","groupId":"OG003","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}],"units":"Participants"}],"description":"The primary objective of the dose-escalation part of this study was to determine the MTD of volasertib in combination with azacitidine. The MTD was to be identified based on the DLT information collected during the first treatment cycle of each dosing schedule. DLT was defined as a non-haematological drug-related toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3. The MTD corresponded to the highest dose of volasertib and azacitidine at which the incidence of DLT was ≤17% (i.e. 1/6 patients) during Cycle 1.\n\nThe planned dose escalation schedules of Part 2 were not completed because the trial was prematurely discontinued. Hence, a final conclusion of the MTD of volasertib in combination with azacitidine cannot be drawn in this trial.\n\nNumber of patients with DLT in cycle 1 in escalation part is presented to determine MTD.","groups":[{"description":"Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)","id":"OG000","title":"Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1"},{"description":"Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)","id":"OG001","title":"Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1"},{"description":"Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)","id":"OG002","title":"Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2"},{"description":"Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)","id":"OG003","title":"Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2"}],"paramType":"NUMBER","populationDescription":"MTD set: The MTD set was used for the first treatment cycle (Cycle 1) analysis and excluded any treated patients that missed any dose of trial medication in Cycle 1 for reasons other than DLT","reportingStatus":"POSTED","timeFrame":"4 weeks","title":"Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in Cycle 1","type":"PRIMARY","unitOfMeasure":"Milligram (mg)"}