{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"6"}],"units":"Participants"}],"description":"Patients were evaluated over the first cycle of treatment for Dose Limiting Toxicities. For this trail DLTs are as follows:\n\nAn AE attributed (definitely, probably, or possibly) to study treatment during cycle 1 and the following criteria:\n\nGrade 4 Neutropenia Grade 4 Thrombocytopenia, or grade 3 with bleeding Febrile neutropenia Creatinine serum great than 2 times baseline or upper limit of normal Grade 3 or higher Fatigue Grade 3 or higher nausea, vomiting, or diarrhea Any grade 3 or higher Non-hematologic toxicity per NCI CTCAE V4.0 Inability to initiate the scheduled cycle 2, day 1 due to toxicity\n\nThe maximum tolerated dose level (MTD) will be defined as the highest safely tolerated dose.","groups":[{"description":"Patients receive 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11.\n\n\\>\n\n\\> Aurora A kinase inhibitor MLN8237: Given orally\n\n\\>\n\n\\> bortezomib: Given IV","id":"OG000","title":"Dose 0**"},{"description":"Patients receive 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.\n\n\\>\n\n\\> Aurora A kinase inhibitor MLN8237: Given orally\n\n\\>\n\n\\> bortezomib: Given IV","id":"OG001","title":"Dose 0"},{"description":"Patients receive 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.\n\n\\>\n\n\\> Aurora A kinase inhibitor MLN8237: Given orally\n\n\\>\n\n\\> bortezomib: Given IV","id":"OG002","title":"Dose 1"},{"description":"Patients receive 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.\n\n\\>\n\n\\> Aurora A kinase inhibitor MLN8237: Given orally\n\n\\>\n\n\\> bortezomib: Given IV","id":"OG003","title":"Dose 2"},{"description":"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.\n\n\\>\n\n\\> Aurora A kinase inhibitor MLN8237: Given orally\n\n\\>\n\n\\> bortezomib: Given IV","id":"OG004","title":"Dose 3"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"28 days","title":"Dose-limiting Toxicity (DLT) (Phase I)","type":"PRIMARY","unitOfMeasure":"participants"}