The University of Alabama at Birmingham is one of eight new institutions, and the only one from Alabama, selected to participate in the Targeted Agent and Profiling Utilization Registry (TAPUR™) Study run by the American Society of Clinical Oncology, Inc. (ASCO®).
The TAPUR Study is the first clinical trial conducted by ASCO, the world’s leading professional organization representing physicians who care for people with cancer. This research study focuses on whether specific targeted therapies can benefit more patients outside of United States Food and Drug Administration-approved uses.
The institutions involved in the expansion of the TAPUR Study were announced at ASCO’s annual meeting in Chicago in June. The study now has more than 325 participants enrolled on a study drug, a nearly threefold increase since the trial launched just over a year ago. With a revised protocol to lower the age of eligibility from 18 to 12 years of age, the TAPUR Study will soon extend the opportunity for participation to adolescent patients with advanced cancer where there is a defined adolescent dose for the study drugs.
“Specifically, the TAPUR Study will add to our expanding portfolio of precision oncology clinical trials,” said Eddy Yang, M.D., Ph.D., professor and vice chair of Translational Sciences in the UAB Department of Radiation Oncology and director of the UAB Molecular Tumor Board. “With the study, we hope to address the important question of whether we can improve clinical outcomes by using tumor profiling to direct targeted cancer therapy.” Yang also leads the precision oncology effort at UAB.
The TAPUR Study will include patients who have any advanced solid tumor, multiple myeloma, or B cell non-Hodgkin lymphoma and are no longer responding to standard anti-cancer treatment or for whom no acceptable standard treatment is available. In addition, the person’s cancer must also have at least one genomic variation that can be targeted with a TAPUR Study drug. This means that a special laboratory test — called a genomic or molecular profiling test — has been performed on a sample of the tumor.
“If a patient has tumor testing results that reveal a genomic variation, the physician will review drugs available on the TAPUR Study that target that variation. The doctor can then choose from one of the drug-cancer-gene matches specified in the study or request a review by the study’s Molecular Tumor Board,” said Yang, a senior scientist at the UAB Comprehensive Cancer Center who serves on the ASCO® TAPUR™ Molecular Tumor Board.
A total of 17 drugs yielding 15 different targeted therapy options (some drugs are used in combination) are available. Seven pharmaceutical companies are currently participating in the study.
All drugs used in the TAPUR Study are approved by the FDA for the treatment of specific types of cancer. However, the study is researching whether those drugs might work in treating other types of cancer as well, so patients may receive a drug approved for a cancer different from their own.
Patients will be screened to determine whether they are healthy enough to participate based on broad inclusion and exclusion criteria.
“It is important to note that not all patients will have a drug-cancer-gene match,” Yang said.
Scientists and clinicians are still working to understand which of the genomic variations play a critical role in cancer development. Recently reported genomic profiling studies performed in patients with advanced cancer suggest that actionable genomic variants are found in 20-40 percent of patients’ tumors.
“The TAPUR Study will help us understand which of the genomic variations can be successfully targeted with FDA-approved cancer drugs,” Yang said. “In oncology, it’s becoming more common to conduct tumor genomic profiling to determine whether or not the results might suggest a previously unrecognized therapy option.”
The TAPUR Study is registered on ClinicalTrials.gov, which includes a 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.
American Society of Clinical Oncology, ASCO, and TAPUR are trademarks of the American Society of Clinical Oncology, Inc., used with permission.