Status:
TERMINATED
ABT-888 and Temozolomide for Liver Cancer
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Abbott
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in abbreviation). The purpose of this study is to test the efficacy (effectiveness) of a new combination of dr...
Detailed Description
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 dat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01205828
Start Date
August 1 2010
End Date
October 1 2014
Last Update
February 12 2025
Active Locations (1)
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1
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007