Study Stopped
Lack of efficacy
ABT-888 and Temozolomide for Liver Cancer
Phase II Study of ABT-888 and Temozolomide in Patients With Advanced Hepatocellular Carcinoma (HCC) Progressing Following Sorafenib Treatment or Intolerant to Sorafenib
1 other identifier
interventional
16
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hepatocellular-carcinoma
Started Aug 2010
Typical duration for phase_2 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 18, 2010
CompletedFirst Posted
Study publicly available on registry
September 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
April 1, 2016
CompletedFebruary 12, 2025
January 1, 2017
4.2 years
September 18, 2010
September 7, 2015
February 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Benefit Rate
complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria
8 weeks
Secondary Outcomes (4)
Overall Survival
2 years
Progression Free Survival
2 years
Number of Participants Who Had Grade 3 or 4 Adverse Events
6 months
Biomarker Analysis
6 months
Study Arms (1)
Temozolomide and ABT-888 in HCC patients
EXPERIMENTALTemozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days
Interventions
Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days
ABT-888 40 mg BID PO Days 1-7 every 28 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Georgetown Universitylead
- Abbottcollaborator
Study Sites (1)
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Related Publications (1)
Gabrielson A, Tesfaye AA, Marshall JL, Pishvaian MJ, Smaglo B, Jha R, Dorsch-Vogel K, Wang H, He AR. Phase II study of temozolomide and veliparib combination therapy for sorafenib-refractory advanced hepatocellular carcinoma. Cancer Chemother Pharmacol. 2015 Nov;76(5):1073-9. doi: 10.1007/s00280-015-2852-2. Epub 2015 Oct 8.
PMID: 26449224DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Aiwu Ruth He
- Organization
- Georgetown University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Aiwu R He, MD PhD
Georgetown University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2010
First Posted
September 21, 2010
Study Start
August 1, 2010
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
February 12, 2025
Results First Posted
April 1, 2016
Record last verified: 2017-01