FEB 27, 2019 03:00 PM PST

BASKET Trials: Biomarker Driven Drug Development

C.E. CREDITS: P.A.C.E. CE | Florida CE
Speakers
  • Professor of Medicine (Oncology) and of Radiology (Molecular Imaging Program at Stanford), Director Phase I Clinical Research, Director, Translational Oncology Program, Stanford University
    Biography
      Dr. Shivaani Kummar is a medical oncologist who specializes in early phase clinical drug development. She is Professor of Medicine and Director of the Phase I Clinical Research, Medical Oncology, and Translational Oncology Programs at Stanford University. She trained in Internal Medicine at Emory University in Atlanta, Georgia, and then pursued her fellowship training at the National Institutes of Health in Medical Oncology and Hematology. She then became Assistant Professor of Medicine at Yale Cancer Center, Yale University School of Medicine, where she developed in an interest in developmental therapeutics. She moved back to the National Cancer Institute (NCI), NIH, to build a clinical research program in novel cancer therapeutics and in 2011 became Head of Early Clinical Trials Development in the Office of the Director, Division of Cancer Treatment and Diagnosis, NCI. She subsequently moved to Stanford University in 2015 to create their early phase program in medical oncology. Her research interests focus on developing novel therapies for cancer, conducting pharmacokinetic and pharmacodynamic driven first-in-human trials. The clinical studies integrate genomics, imaging, and laboratory correlates into early phase trials. She serves on multiple national and international committees, and has widely published in high impact peer reviewed journals. She also serves as the Associate Division Chief for Medical Oncology.

    Abstract:

    Dramatic responses observed with targeted agents in the ‘right’ genomic context have fueled large scale sequencing efforts to identify ‘effective’ treatments for a given patient. In order to expeditiously evaluate a targeted agent against a potential ‘driver’ genetic aberration, so-called Basket trials are conducted. Basket trials enroll patients with multiple tumor types that carry a common genetic aberration and evaluate a single targeted treatment regimen. I will discuss the rationale, design, and challenges in conducting Basket trials.

    Learning Objectives:

    1. Learn about when to consider conducting a Basket trial and how to design it
    2. Learn about the promises and challenges of identifying patients based on genomic aberrations
     


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