(APR-407) PiSARRO: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin/Pegylated Liposomal Doxorubicin (PLD) Combination Chemotherapy With or Without APR-246
The purpose of this study is to test whether a treatment of usual care carboplatin/pegylated liposomal doxorubicin (PLD) chemotherapy combined with investigational drug APR-246 provides any benefit to treatment with carboplatin/PLD alone in women with recurrent, platinum-sensitive high-grade serous ovarian cancer that has mutation in a gene called P53.
1. Confirmed high-grade serous ovarian cancer (HGSOC), fallopian tube cancer, or primary peritoneal cancer with disease progression between 6-24 months after a first- or second-line platinum-based chemotherapy
2. Archived tumor sample to test for p53 mutation status; only those patients with tissue that tests positive for p53 mutation will be eligible.
3. Presence of at least one measurable lesion (tumor)
6. Other inclusion/exclusion criteria will apply
18 - 99
Healthy Volunteers Needed
Duration of Participation
You will receive study treatments and undergo study procedures for up to 6 months unless your disease progresses, you experience side effects that are not well-tolerated, you decide to withdraw from the study, or the investigator and/or study sponsor remove you from the trial. After your study participation ends, the investigator and/or your cancer doctor will discuss with you your treatment options. You will continue to be followed by the study every 3 months until your disease progresses.
OHSU Gynecologic Oncology Study Coordinator
or Knight Cancer Institute Clinical Trials Information Line