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TAPUR trial expands access to more cancer patients
TAPUR trial expands access to more cancer patients
Researchers have launched a new study that aims to expand access to drugs for some patients with advanced cancers and to collect and share data about individual responses to drugs not yet approved for certain types of cancer. The Target Factor and Use Profiling Registry (TAPUR) study is for patients who have undergone genetic testing that has revealed that their tumors have a mutation that can be treated with drugs approved for other cancers. Study participants will be able to access these drugs at no cost, even if the drugs have not been approved by the US Food and Drug Administration (FDA) for their type of cancer. The American Society of Clinical Oncology (ASCO) is leading the trial.
future wave
“This is the future of cancer research,” says Dr. Murray Markman, chief of medicine and science at Cancer Treatment Centers of America. ® (CTCA). “This ASCO-led trial focuses on what we can find inside an individual patient’s cancer that can help determine the best treatment. Rather than relying treatments on large numbers of patients, we look at the individual patient’s tumor. This will be the new paradigm as we move forward. “.
The goal is to improve the prognosis of study patients, which could lead to more FDA-approved drug treatment options for more cancers in the future. “By participating in the TAPUR trial, we hope to learn how well the drugs work by targeting mutations in other cancers, types that are not currently approved,” says Dr. Glenn Weiss, director of Phase I Research and Clinical Trials. Secondly. At Phoenix Area Hospital. “If we see exceptional success, it could lead to new indications for approval and broader access to these drugs, using a potentially time-consuming pathway with traditional clinical trial designs.”
TAPUR is a “non-randomised” study, meaning that each eligible participant will be treated with a medication compatible with the tumor and no participant will receive a placebo. The study is designed to allow for broader participation than most clinical trials, but all patients will be evaluated to determine if they are healthy to participate and meet other eligibility criteria.
Who qualifies for TAPUR?
Eligible patients must have an advanced solid tumor, multiple myeloma, or B-cell non-Hodgkin’s lymphoma and have exhausted standard therapies or have no available options. Also, because this trial will only study treatments used outside of their FDA-approved indications, patients are only eligible if drugs that match their mutation have not been approved to treat their type of cancer. For example, an adult patient “Judy” had lung cancer with a specific mutation identified by genome testing and had no standard treatment options. There is a drug available in the TAPUR study designed to target your mutation, but the drug is only approved to treat skin cancer, not lung cancer. At TAPUR, you have access to this drug, but a melanoma patient with the same mutation will not be eligible for the study.
Seven drug companies — Bayer, Merck Sharp & Dohme, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, Genentech and Pfizer — are taking part in the study, offering a total of 17 drugs. Hospitals across the country, including the five CTCA® hospitals, are enrolling eligible patients.
“What we have here is not just a drug or a molecule defect,” says Dr. Markman. “We have many molecular abnormalities, many drugs, many companies involved in this trial. This trial changes the whole language of clinical cancer research. It changes the thinking processes about how oncologists treat cancer.”
More information about the TAPUR study.