CLINICAL TRIAL: SUBJECTS WITH (MDS) RECEIVING HYPOMETHYLATIN AGENTS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a Phase 2 multi-center, randomized, double-blind, placebo-controlled, simultaneous treatment group, dose finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving a hypomethylating agent. Subjects with MDS diagnosed by a bone marrow biopsy and an International Prognostic Scoring System (IPSS) rating of low, intermediate-1 or intermediate-2 risk MDS that are planned to receive at least four cycles of a hypomethylating agent for treatment of their disease are appropriate to screen for this study. This study will be composed of a part A and a part B. The tests and procedures for all visits will be the same in part A and part B except for the administration of the hypomethylating agent. Subjects in part A will receive investigational product in combination with azacytidine. Subjects in part B will receive investigational product in combination with decitabine. Part A will be completed and evaluated prior to opening part B for enrollment. The dose for part B will be determined by the Data Review Team (DRT) after their review of the analysis of part A. The analysis of Part A and Part B will be conducted using the same endpoints and methods of analysis. The total estimated duration of the study is 24 months and a maximum of 315 patients ( 264 in part A and 51 subjects in part B) will be enrolled in all sites which will be approximately 60 centers in the United States.