Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer

This is a phase II clinical trial, that administers a maintenance treatment after first line
chemotherapy is complete. It is designed to have a 1:1 randomization technique. Half the
participants who enter the study will receive the active ingredient, Rucaparib, while the
other half will receive a placebo. Treatment will be until progression with follow up until
death.

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the
following criteria:

1. Provision to sign and date the consent form.

2. Stated willingness to comply with all study procedures and be available for the
duration of the study.

3. Be a female aged 18-89.

4. Patients with a primary Stage III/IV or recurrent endometrial cancer.

5. Patients have received at least one prior chemotherapy regimen and no more than two
prior cytotoxic regimens (including hormonal therapy).

6. Primary chemotherapy regimen must have consisted of at least 4 completed cycles and no
more than 8 completed cycles.

7. Previous cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks
from initiation after last dose of previous therapy.

8. 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.

9. ECOG performance status of 0, 1 or 2.

10. ANC > or = 1500 cells/microliters

11. Platelet count > 100,000 microliters

12. Hemoglobin > or = 9.0 g/dL

13. Serum albumin > or = 2.5 g/dL

14. Total bilirubin ≤ 1.5 x ULN

15. AST and ALT ≤ 3.0 x ULN

16. Serum Creatinine ≤ 1.5x ULN

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation
in this study:

1. Inability to comply with study and follow-up procedures

2. 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

3. 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

4. Participation in investigational clinical trial within last 30 days

5. History of significant chronic disease including HIV/AIDS or hepatitis C

6. Inability to provide informed consent

7. Known CNS malignancy or CNS metastases

8. 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.

9. History of stroke or transient ischemic attack (TIA) within 3 months prior to cycle 1
day 1(C1D1)

10. Major surgical procedure within 28 days prior to C1D1 or anticipation of needing a
major surgical procedure during the course of the study

11. Women with prognosis for survival less than 6 months

12. Patients who have progressed or have stable disease (SD) through most recent
chemotherapy regimen

13. Patients deemed otherwise clinically unfit for clinical trial per Investigator's
discretion

14. Patients with duodenal stent or other GI disorder/defect that would interfere with
absorption of oral medication

15. Female patients who maintain fertility potential and refuse to comply to use
contraception and be followed for pregnancy by pregnancy testing

16. Non-study related minor surgical procedure < or = 5 days or major surgeries < or = 21
days prior to first dose of treatment