Global Coalition for Adaptive Research (GCAR), an expert in developing and operationalizing adaptive platform trials and master protocols, is sponsoring the development and implementation of a new protocol — Ovarian CanceRxTM.
Ovarian CanceRx will identify safe and efficacious treatment options to address a diverse array of mutations and treatment resistance in newly diagnosed and recurrent ovarian cancer patients. GCAR brings an “adaptive” clinical trial infrastructure by which the drug development community can test multiple drugs and combinations of drugs simultaneously against the standard of care.
There are nearly 300,000 new cases of ovarian cancer diagnosed yearly worldwide.
Ovarian cancer is a global problem affecting women of all ages. While ovarian cancer is a rare disease, accounting for only 1.7% of all cancers in women in the U.S. between 2013 and 2017, it accounted for almost 7% of cancer deaths in that period. Ovarian cancer is the fifth leading cause of cancer-related deaths in women and accounts for more deaths than any other cancer of the female reproductive system. An estimated 1 in 78 women will develop ovarian cancer during her lifetime.
Even with the numerous randomized control trials in ovarian cancer, there still remains an unmet need in this field.
THE OVARIAN CANCERx STRATEGY
Ovarian CanceRx will identify science-driven treatment options for women with newly diagnosed or recurrent ovarian cancer. Ovarian CanceRx uses an adaptive clinical trial infrastructure by which multiple drugs and drug combinations can be tested simultaneously against the standard of care treatment options in order to rapidly develop and deliver new therapeutics to patients suffering from ovarian cancer.
OVARIAN CANCERx BENEFITS
This innovative platform trial is designed to rapidly test new treatment regimens for women with newly diagnosed or recurrent ovarian cancer.
Multiple interventions will be tested against standard of care with interventions entering and exiting the trial over time based on a decision algorithm.
Unique design will allow patients that develop drug resistance to re-enroll in different study arms, which will provide patients more options for their care.
Will serve as a distinctive, information rich platform of longitudinal data with opportunities to explore tumor molecular genetics and characterization.
The goal is better alignment between clinical practice and clinical research to allow for increased access to experimental therapies for patients while maximizing what is learned to speed the development of new therapies and biomarkers. This will help to usher in a new generation of effective treatments for high grade ovarian cancer.