Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-26 @ 10:37 AM
NCT ID:
NCT01205828
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01205828
Study Brief:
Protocol Section:
NCT01205828