The ReDiscover clinical research study is a clinical trial for people who have metastatic cancer with a PIK3CA mutation. The clinical trial will test a new investigational drug to learn if it can target and inhibit the PI3K protein that is created incorrectly by a mutated PIK3CA gene.
Study participants may be able to join the study if they meet the following requirements:
- • Adult (18 years of age or older)
- • Have metastatic cancer with a documented PIK3CA mutation.
- • Qualifying cancers include breast cancer, clear cell ovarian, head and neck, cervical, and others. Your oncologist can help you confirm if you have a PIK3CA genetic mutation.
*Additional eligibility criteria apply.
Study participants can expect the following:
- Review & sign the Informed Consent Form.
- Screening (up to 28 days): Receive study health assessments including a physical history, blood and urine tests, and heart tests, among others to confirm if you qualify for the study.
- Treatment period (3 months to a year or longer, depending on response to study treatment): You will take the study drug for as long you are benefitting from it. Participants with breast cancer may also receive fulvestrant (an approved cancer drug) as injections about every 2 weeks for the first 3 doses and then about once a month. These participants may also receive palbociclib or ribociclib (both approved cancer drugs) as tablets to take by mouth once daily for the first 21 days of each 28-day cycle.
- Follow-up period (every 12 weeks): Receive study health assessments.
Participation in this clinical trial is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.