R Charlab Orbach

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3106 Background: Tyrosine kinase inhibitors (TKIs) interfere with several critical signal transduction pathways in cancer. Nine TKIs have been FDA approved to treat a variety of malignancies. TKIs have been associated with severe liver injury (SLI). Whether this liver injury is a class effect, or specific to certain TKIs is being investigated. METHODS(More)
3060 Background: Optimized phase 1 (ph1) clinical trials may increase the likelihood of successful oncology drug development. We developed a FDA knowledge management (KM) database that allows comprehensive assessment of ph1 trial features. Here we pilot whether the database can catalogue diversity in early phase studies of the PI3K inhibitor drug class. (More)
2597 Background: FDA drug approval requires demonstrated efficacy in adequate, well-controlled trials. In oncology, two key questions should be asked prior to initiation of "pivotal" efficacy trials: 1) which patient subsets should be enrolled into efficacy trials; and 2) what dose(s) should be tested? Improved phase 1 (P1) trials may help answer these(More)
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