This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatment temozolomide + abt-888
Phase phase 2
Sponsor Georgetown University
Collaborator Abbott
Start date August 2010
End date December 2013
Trial size 49 participants
Trial identifier NCT01205828, 2009-268


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 drugs, ABT-888 and temozolomide for patients with liver cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide and will hopefully increase the killing of cancer cells, and decrease the tumors in the body.

ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in liver cancer.

This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888, has on liver cancer.

This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide in liver cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Temozolomide and ABT-888
temozolomide + abt-888 ABT-888
Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months).

Primary Outcomes

clinical benefit rate
time frame: 1 year

Secondary Outcomes

overall survival
time frame: 2 years
Progression free survival
time frame: 2 years
Safety assessment
time frame: 6 months
Biomarker analysis
time frame: 2 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study of ABT-888 and Temozolomide in Patients With Advanced Hepatocellular Carcinoma (HCC) Progressing Following Sorafenib Treatment or Intolerant to Sorafenib
Principal investigator Aiwu R He, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Georgetown University.