The purpose of this study is to evaluate the optimal dose of 2X-121 as single agent therapy at 600 mg daily (split BID 200 mg morning + 400 mg evening) compared to 800 mg daily (split BID 400 mg morning + 400 mg evening) in recurrent, advanced ovarian cancer patients that have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible. The optimal dose will be selected based on an integrated analysis of PK/PD, safety, and efficacy data.
Signed informed consent form.
Age 18 years or older.
Histologically or cytologically documented epithelial ovarian, fallopian tube, or primary peritoneal tumors, with high-grade serous or endometrioid, or predominantly serous/endometrioid histology (independent of BRCA1 and HRD status).
Patients must have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible.
Patients who have platinum-refractory disease, defined as progression during the last platinum-based chemotherapy.
Concurrent chemotherapy, antibody therapies radiotherapy,hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period.
Other malignancy with exception of any stage I and II cancer that is deemed cured by the Investigator.
Any active infection requiring parenteral or oral antibiotic treatment.