Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer

Prior treatment

• History of stroke or transient ischemic attack (TIA) within 3 months prior to cycle 1 day 1(C1D1)
• Minor surgical procedure \< or = 14 days or major surgeries \< or = 28 days prior to first dose of treatment

Other illness

• Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the past 3 months, unstable arrhythmias, or unstable angina
• History of significant chronic disease including HIV/AIDS or hepatitis C
• Known central nervous system (CNS) malignancy or CNS metastases
• Patients with previous malignancy, other than endometrial, within the past 2 years from cycle 1, day 1, with the exception of those with negligible risk of metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the breast.
• Patients who have progressed or have stable disease (SD) through most recent chemotherapy regimen
• Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication

Lab values

• Known clinically significant liver disease defined as AST and ALT \> 3.0 x ULN and/or Total bilirubin \> or = 1.5 x ULN, or documented history of active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease

Other

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Inability to comply with study and follow-up procedures
• Participation in investigational clinical trial within last 30 days
• Inability to provide informed consent
• Women with prognosis for survival less than 6 months
• Patients deemed otherwise clinically unfit for clinical trial per Investigator's discretion
• Female patients who maintain fertility potential and refuse to comply to use contraception and be followed for pregnancy by pregnancy testing

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Provision to sign and date the consent form.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Be a female aged 18-89.
• Patients with a primary Stage III/IV or recurrent endometrial cancer.
• Patients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy).
• Primary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles.
• Previous cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy.
• Patients who receive radiation to the whole pelvis or at least 50% of the spine must complete radiation therapy and have at least 4 weeks' time elapse prior to initiation of drug.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
• Absolute neutrophil count (ANC) \> or = 1500 cells/microliters
• Platelet count \> 100,000 microliters
• Hemoglobin \> or = 9.0 g/dL
• Serum albumin \> or = 2.5 g/dL
• Total bilirubin ≤ 1.5 x ULN (uppler limit of normal)
• AST and ALT ≤ 3.0 x ULN
• Serum Creatinine ≤ 1.5x ULN