Introduction to the TAPUR Study, with Richard Schilsky, MD, FACP, FASCO

July 19, 2016
Download MP3 (7.38 MB/8:03)

In today’s podcast, ASCO’s Chief Medical Officer, Dr. Richard Schilsky, discusses ASCO’s first-ever clinical trial, the Targeted Agent and Profiling Utilization Registry, or TAPUR Study. The TAPUR Study is a clinical trial for people with later-stage cancer, focused on whether specific targeted therapies can benefit more patients and lead to more personalized treatments.  Dr. Schilsky explains the objectives of the study, and provides information about who might be eligible to participate, as well as what is involved.

Transcript: 

ASCO: You're listening to a podcast from Lineagotica. This cancer information website is produced by the American Society of Clinical Oncology, known as ASCO, the world's leading professional organization for doctors that care for people with cancer.

In today's podcast, ASCO's Chief Medical Officer, Dr. Richard Schilsky discusses ASCO's first ever clinical trial, the Targeted Agent and Profiling Utilization Registry, or TAPUR Study. The TAPUR Study is a clinical trial for people with later-stage cancer, focused on whether specific targeted therapies can benefit more patients, and lead to more personalized treatments. Dr. Schilsky explains the objectives of the study and provides information about who might be eligible to participate, as well as what is involved. ASCO would like to thank Dr. Schilsky for discussing this study.

Dr. Schilsky: I'm Dr. Richard Schilsky. I'm a medical oncologist and the Chief Medical Officer at the American Society of Clinical Oncology. And I'm the principal investigator for ASCO's TAPUR Study. TAPUR is an acronym that stands for Targeted Agent and Profiling Utilization Registry. TAPUR is ASCO's first clinical trial, and it's a study intended to learn about the use of targeted anti-cancer drugs prescribed outside of their usual FDA approved indications for treatment of patients with advanced cancer. So why did ASCO decide to start this study? We made observation that these days there's a lot of genomic testing going on of patients tumors looking for genomic abnormalities, in the tumor, that might identify a opportunity for treatment, that wasn't already considered by the patient's physician. Particularly in patients with far advanced cancer who've already had all the standard treatment options. We know that the technology exists, the testing exists to do the genomic profile on the patient's tumor. And in some cases, an abnormality is identified that leads to treatment with a targeted drug that might not otherwise have been tried, and produces a very beneficial response.

So understandably, patients who are seeking to determine what their treatment options are, are interested in getting this type of genomic profiling done. Doctors are interested in doing it. The testing is widely available, but even under those circumstances, there are a few problems that develop. One is, of course, that if the testing identifies a drug that might be appropriate to try in the patient's case, it's often difficult for the patient to actually get access to the drug. In many cases, the drugs are either still experimental, and they're only available in clinical trials, or even if the drug is already commercially available for one kind of cancer, it's typically not FDA approved for the patient's kind of cancer. And in that case, often times the drug is not covered by the patient's insurance. So it's difficult for them to get access to the drug. And more importantly, I think, from the larger medical research perspective, even if the patient is able to get access to the drug, and receive the treatment, often times there's no information that's really ever captured, or reported to the larger medical community on how that patient did.

So there's no opportunity for other patients, and the medical community, to learn from the patient's experience of receiving that targeted drug. So TAPURs been designed to really solve both of these problems. We've been fortunate to have seven drug companies collaborate with us, and provide 17 targeted anti-cancer drugs for the study that will be available to patients at no cost to them, or to their insurance companies. Each of these drugs are already FDA-approved drugs used in treating some kind of cancer, but within the context of the study will be used outside of their labeled indications. Because TAPUR is a research study, patients do have to provide informed consent to participate, and they do have to meet certain eligibility criteria to join the study. Although, the study is designed to be fairly broad in its eligibility criteria to allow as many patients as possible to participate.

Importantly, through their participation in the study, we're able to capture information on their experiences, for side effects that they experience from the treatments, and the outcomes of their cancer treatment. So we learn about whether or not the drugs actually work in their kind of cancer, with whatever the particular genomic abnormality is that was identified in the tumor profiling report. To be eligible to participate in TAPUR, patients must have already had a genomic profiling test performed on their tumor. That's a decision that the patient can make with their physician. The genomic profiling testing is not provided by the study, and there's no particular test that's required by the study. It's really up to the doctor to determine what's the best test to do on the patient's tumor. Once those results are in hand, if the patient meets the general eligibility criteria for the study, they can then enroll in the protocol, and the doctor can then determine whether or not one of the TAPUR Study drugs is an appropriate match for the genomic abnormalities present in the patient's tumor.

If so, and if the patient needs any drugs specific eligibility criteria to participate in the study, then they can go on and receive the treatment as specified by the protocol. They're evaluated after every two months of treatment to determine if the treatment is helping, or not, and patients can remain on the treatment as long as there's evidence that the tumor is not growing, or is in fact shrinking. So that's pretty much the way the TAPUR Study works. Eligible patients are those who have any advanced solid cancer, Non-Hodgkin Lymphoma, or Multiple Myeloma, and who no longer have any standard treatment options available to them. They have to be up and out of bed at least 50% of the time. They have to have relatively normal kidney and liver function to be able to participate in the study. The study is currently enrolling patients at a limited number of clinical sites in the states of North Carolina and Michigan, but we anticipate that the beginning, in the second half of this year, to rapidly expand the number of sites around the country where the study is available. So we hope that this is a good introduction to the TAPUR Study and if you're interested in more information please visit the TAPUR website at www.tapur.org. Thanks very much.

ASCO: Thank you Dr. Schilsky. For more information about the TAPUR Study visit lineagotica.info/tapur and www.tapur.org/patients. And for more expert interviews and stories from people living with cancer, visit the Lineagotica Blog at lineagotica.info/blog.

Lineagotica is supported by the Conquer Cancer Foundation, which is working to create a world free from the fear of cancer by funding breakthrough research, sharing knowledge with physicians and patients worldwide, and supporting initiatives to ensure that all people have access to high-quality cancer care. Thank you for listening to this Lineagotica podcast.