“We are gratified with the high degree of interest and participation in the TAPUR Study. Clinical sites and patients are clearly eager to be a part of this study and are enrolling more quickly than we had anticipated,” said ASCO Chief Medical Officer Richard L. Schilsky, MD, FACP, FASCO. “There’s an urgent need to explore new therapeutic options for patients with advanced solid tumor cancers, multiple myeloma, or B-cell non-Hodgkin lymphoma. TAPUR provides a unique venue to enable multistakeholder collaboration to learn about additional uses of targeted drugs that already have U.S. Food and Drug Administration [FDA] approval in one or more cancers. The rapid enrollment in TAPUR will allow us to identify new signals of drug activity as quickly as possible.”
In the 8 months since the trial opened, 174 individuals have consented to participate, and 105 participants have begun receiving a TAPUR Study drug.
The five centers that have most recently begun patient recruitment will offer TAPUR at multiple locations, for a total of 25 new site locations, which will be fully up and running over the next few months. They are:
New Additions to TAPUR
Seven pharmaceutical companies are currently participating: AstraZeneca, Bayer, Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Merck, and Pfizer. Among them, they provide 17 drugs that yield 15 different targeted therapy options (since some of the drugs are used in combination). ASCO has designed the TAPUR Study to facilitate the inclusion of additional drugs and companies as the trial continues and expects to offer additional regimens in the near future.
In addition, study leaders are planning to decrease the enrollment age from 18 to 12 years to extend the opportunity for participation to adolescent patients with advanced cancer, where there is a defined adolescent dose for the study drugs.
The TAPUR Study is designed to evaluate molecularly targeted cancer drugs and collect data on clinical outcomes to learn about additional uses of these drugs outside of indications already approved by the FDA. ASCO is using Syapse Precision Medicine Platform to automate the matching of patients to treatments based on genomic and clinical profiles; facilitate study workflows; and integrate clinical, genomic, treatment, and outcomes data.
ASCO is working with the Research Advocacy Network to conduct a TAPUR substudy, which will provide insights to help the oncology community understand how tumor genomic testing is being used by clinical oncologists and how to provide assistance with provider and patient education. ASCO is also collaborating with the Netherlands Center for Personalized Cancer Treatment on its Drug Rediscovery Protocol (DRUP) trial, which is similar to TAPUR and also opened earlier this year. Other international centers and research networks have expressed interest in developing versions of the TAPUR and DRUP protocols in their regions of the world. Doing so has the potential to create a global network to discover new uses of already approved targeted cancer treatments.
The TAPUR Study is registered on ClinicalTrials.gov (identifier = NCT02693535), which includes a full list of inclusion/exclusion criteria and other information. Patients can find study information such as general eligibility criteria, participating clinical sites, and contact information for the study team at www.TAPUR.org. Researchers and practices interested in participating can fill out the TAPUR Study Site Questionnaire or contact the study team at http://www.tapur.org/contact-us. To watch a video that provides an overview of the TAPUR study, visit https://www.youtube.com/watch?v=ALdODwWDtCY. ■
© 2016. American Society of Clinical Oncology. All rights reserved.