Rutgers Cancer Institute located in New Brunswick, New Jersey, announced it is opening up enrollment for a new clinical trial to investigate ONC201, a novel anti-cancer drug designed by Oncoceutics Inc. The trial is intended to study the effectiveness of ONC201 in the treatment of solid tumors such as colon cancers in patients whose disease has stopped responding to traditional therapies.
Clinical trials for new cancer drugs are most often used to test new treatments for patients who are no longer responding to standard therapies. ONC201 has been studied in the laboratory and showed promising results, consistently killing cancer cells but did not affect non-cancerous normal cells. This will be the first study of the drug in humans and it will involve the following phases:
- Phase I will evaluate the safety of ONC201 in patients with advanced cancer and will help develop the exact dosing needed for Phase 2 of the trial
- Phase II will evaluate the treatment success of ONC201 in selected types of cancer
In a press release, Dr. Mark Stein, MD, medical oncologist at the Cancer Institute, assistant professor of medicine at Rutgers Robert Wood Johnson Medical School, and the trials’ lead investigator, stated “By exploring a novel agent that targets the cancer but leaves non-cancerous tissue untouched, we have an opportunity to not only provide a new treatment option for patients who have exhausted standard forms of therapy, but to also offer them a therapeutic that may result in a better quality of life since healthy cells are not impacted.”
Dr. Stein’s colleague, Dr. Howard L. Kaufman, MD, Chief Surgical Officer and associate director for clinical science at the Cancer Institute and professor of surgery at Robert Wood Johnson Medical School, added, “As a National Cancer Institute-designated Comprehensive Cancer Center, it is part of our mission to bring novel therapeutics to clinical practice. With that, we are pleased to be the first clinical site to offer ONC201 to patients in need of new therapies.”
To be eligible for the trial potential patients must meet the following qualifications:
- Be 18 and older
- Diagnosed with a solid tumor (those that do not involve blood, bone marrow or lymph nodes) for which commonly used treatments no longer work
- Be willing to undergo a physical exam and have blood taken
Accepted patients will receive two doses (cycles) of ONC201 in pill form by mouth every 21 days. After the second cycle, patients will undergo a four week study evaluation.
Rutgers Cancer Institute of New Jersey is the state’s first and only National Cancer Institute-designated Comprehensive Cancer Center. As part of Rutgers, The State University of New Jersey, the Cancer Institute of New Jersey is dedicated to improve the detection, treatment and care of patients with cancer, and to serve as an education resource for cancer prevention. Physician-scientists at the Cancer Institute engage in translational research, transforming their laboratory discoveries into clinical practice, quite literally bringing research to life.