ABT-888 and Temozolomide for Liver Cancer

Patients with hepatocellular carcinoma seen at Lombardi Cancer Center were evaluated for the
eligibility of this study.

The Georgetown Lombardi Comprehensive Cancer Center was responsible for the data and safety
monitoring of this trial. As this study is an investigator initiated study Phase II study
utilizing a non-FDA approved drug for which the PI held the IND it was considered a high
risk study which had real-time monitoring by the PI and study team and quarterly reviews by
the LCCC Data and Safety Monitoring Committee (DSMC).

Inclusion Criteria:

- Pathological confirmation of HCC or noninvasive criteria following AASLD guidelines

- Measurable or evaluable disease based on RECIST criteria

- Progressive disease on sorafenib or intolerance to sorafenib

- ECOG performance status 0-2

- Child Pugh Class A or B

- Adequate hepatic, bone marrow, and renal function

Exclusion Criteria:

- Prior ABT-888 or other PARP inhibitor treatment

- Anticipation of need for major surgery during the study

- Any of the following within 6 months before enrollment: myocardial infarction,
severe/unstable angina, congestive heart failure, or severe pulmonary disease

- Women who are pregnant or lactating

- Women and men of child-bearing potential who are not using a reliable form of
contraception

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to ABT-888 and temozolomide

- Concurrent malignancy (i.e. malignancy other than hepatocellular cancer) unless 1)
the subject has been curatively treated and disease free for at least 2 years or 2)
the cancer was non-melanoma skin cancer or early cervical cancer.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection (excluding active hepatitis B or C) or psychiatric illness/ social
situations that would limit compliance with study requirements