A Phase II Open-Label Study of NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
This study was designed to evaluate the effect of two dose levels of NUC-1031 (500 mg/m2 and 750mg/m2) in patients with ovarian cancer. The primary objective was to determine the anti-tumor activity of NUC-1031 at the selected dose level (500 mg/m2 or 750 mg/m2).
• Provision of signed written informed consent.
• Original diagnosis and/or histological confirmation of high-grade serous, high-grade endometrioid, undifferentiated/unclassifiable epithelial ovarian, fallopian tube or primary peritoneal cancer.
• Time from the last line of platinum-based chemotherapy of less than 6 months.
• Received at least 3 prior chemotherapy-containing regimens.
• Age ≥18 years.
• Ability to comply with protocol requirements.
• Patients are not of childbearing potential or they must agree to use a physical method of contraception.