{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Andreeff M"],"funding":["Hoffmann-La Roche, Inc. NIH","Medical Research Council","NCI NIH HHS"],"pagination":["868-76"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC4809642"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["22(4)"],"pubmed_abstract":["<h4>Purpose</h4>RG7112 is a small-molecule MDM2 antagonist. MDM2 is a negative regulator of the tumor suppressor p53 and frequently overexpressed in leukemias. Thus, a phase I study of RG7112 in patients with hematologic malignancies was conducted.<h4>Experimental design</h4>Primary study objectives included determination of the dose and safety profile of RG7112. Secondary objectives included evaluation of pharmacokinetics; pharmacodynamics, such as TP53-mutation status and MDM2 expression; and preliminary clinical activity. Patients were divided into two cohorts: Stratum A [relapsed/refractory acute myeloid leukemia (AML; except acute promyelocytic leukemia), acute lymphoblastic leukemia, and chronic myelogenous leukemia] and Stratum B (relapsed/refractory chronic lymphocytic leukemia/sma"],"journal":["Clinical cancer research : an official journal of the American Association for Cancer Research"],"pubmed_title":["Results of the Phase I Trial of RG7112, a Small-Molecule MDM2 Antagonist in Leukemia."],"pmcid":["PMC4809642"],"funding_grant_id":["MC_UU_12009/11","P01 CA049639","P30 CA016672","P01 CA49639 and CA16672","P01 CA49639","CA16672","G1000801c","P50 CA100632"],"pubmed_authors":["Assouline S","Iyer SP","Andreeff M","Ruvolo V","Vyas P","Kirschbaum M","Nichols G","Gonzalez GM","Middleton S","Zhi J","Chen G","Rueger R","Kelly KR","Kojima K","Drummond MW","Bridge P","Strair R","Yee K","Martinelli G","Reckner M","Popplewell L","Bowen D","Huang X","Blotner S","Graves B","Jukofsky L"],"additional_accession":[]},"is_claimable":false,"name":"Results of the Phase I Trial of RG7112, a Small-Molecule MDM2 Antagonist in Leukemia.","description":"<h4>Purpose</h4>RG7112 is a small-molecule MDM2 antagonist. MDM2 is a negative regulator of the tumor suppressor p53 and frequently overexpressed in leukemias. Thus, a phase I study of RG7112 in patients with hematologic malignancies was conducted.<h4>Experimental design</h4>Primary study objectives included determination of the dose and safety profile of RG7112. Secondary objectives included evaluation of pharmacokinetics; pharmacodynamics, such as TP53-mutation status and MDM2 expression; and preliminary clinical activity. Patients were divided into two cohorts: Stratum A [relapsed/refractory acute myeloid leukemia (AML; except acute promyelocytic leukemia), acute lymphoblastic leukemia, and chronic myelogenous leukemia] and Stratum B (relapsed/refractory chronic lymphocytic leukemia/sma","dates":{"release":"2016-01-01T00:00:00Z","publication":"2016 Feb","modification":"2025-04-26T00:57:52.776Z","creation":"2019-03-27T03:10:24Z"},"accession":"S-EPMC4809642","cross_references":{"pubmed":["26459177"],"doi":["10.1158/1078-0432.CCR-15-0481","10.1158/1078-0432.ccr-15-0481"]}}