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ASCO Reveals First-Ever Clinical Trial


American Society of Clinical Oncology - June 1, 2016 Targeted Agent and Profiling Utilization Registry (TAPUR) study evaluates molecularly-targeted cancer drugs.

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Dr. Richard Schilsky, Chief Medical Officer, ASCO: The TAPUR study (Targeted Agent and Profiling Utilization Registry) is a prospective large sort of what we would now call a "basket trial". It began as an idea to do an observational study - a registry study - to just observe how oncologists were implementing precision medicine in clinical oncology practice. But as we developed the idea, it seemed like it would actually be more feasible and more informative to actually do something that resembles more of a Phase II clinical trial with multiple treatment arms.
Dr. Julie Vose, Internist, University of Nebraska: The TAPUR study is really groundbreaking in that it's, of course, ASCO's (American Society of Clinical Oncology) first clinical trial, and it's also a way to not only get the information that's being gathered in clinical practice, but allow the patients to get access to drugs that are currently FDA-approved for other purposes. And only about 3% of adult patients participate in oncology clinical trials, so this is a way to enhance that, to get more patients onto clinical trials, and gather the information to be able to take that forward to future patients.
RS: We have two overarching goals with TAPUR: One is to use it as a vehicle to identify signals of drug activity in tumor types where the drug is not known to be an effective drug. Trying a drug that is FDA-approved for use in a certain kind of cancer that has a certain genomic profile, trying that drug in a different kind of cancer with a similar genomic profile and finding out whether or not there's any signal of activity there, opens up new opportunities to further study that drug. A secondary and equally important goal is to use TAPUR as a vehicle to help educate oncologists about this whole area of precision medicine. How does it work? How do you interpret a genomic test? What does the information really mean? How do you use the genomics to guide you to the selection of a particular drug for a patient? How do you evaluate the drug in the context of that patient's genomic findings? And so on. But there's a tremendous amount of information that could potentially inform the whole oncology community that is never provided to them because it's never captured or reported in any way. We have been very fortunate to have pharmaceutical companies donate marketed drugs to the TAPUR study. The drugs were provided free of charge, and if the patient is eligible and consents to participate in the study, they guarantee that they'll be able to get the drug.
JV: Different pharmaceutical agents will be utilized to see if the patients respond to that, and what the side effects are, and what the patients' ultimate outcomes are. This is done sometimes routinely in clinical practice, but without the patients being in a clinical trial, we can't gather that information. And this is an ability to get the drug to the patient and also gather the information from the patient taking that medication.

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