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 oncologists. This research study focuses on whether specific targeted therapies can benefit more patients outside of FDA-approved uses.
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.
"The TAPUR Study will add to our expanding portfolio of precision oncology clinical trials," said Eddy Yang, MD, PhD, professor and vice chair of Translational Sciences in the UAB Department of Radiation Oncology. "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."
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.
"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," Yang said.
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.
"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 to 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.