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ABT-888 and Temozolomide for Liver Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01205828
Recruitment Status : Terminated (Lack of efficacy)
First Posted : September 21, 2010
Results First Posted : April 1, 2016
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):
Ruth He, Georgetown University

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Temozolomide Drug: ABT-888 Phase 2

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 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2010
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: Temozolomide and ABT-888 in HCC patients
Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days
Drug: Temozolomide
Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days
Other Name: Temodar

Drug: ABT-888
ABT-888 40 mg BID PO Days 1-7 every 28 days
Other Name: Veliparib

Primary Outcome Measures :
  1. Clinical Benefit Rate [ Time Frame: 8 weeks ]
    complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]
    the number of months between a patient's enrollment and his/her date of death

  2. Progression Free Survival [ Time Frame: 2 years ]
    The number of months between a patient's enrollment and his/her disease progression

  3. Number of Participants Who Had Grade 3 or 4 Adverse Events [ Time Frame: 6 months ]
    Record of all toxicities graded according to the NCI CTCAE version 3.0

  4. Biomarker Analysis [ Time Frame: 6 months ]
    To evaluate biological correlation with response to ABT-888 and temozolomide, including evaluation of loss of heterozygosity (LOH) of 13q, decreased expression of or mutations in BRCA-1 or -2, and a select assortment of DNA repair genes.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01205828

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United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
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Principal Investigator: Aiwu R He, MD PhD Georgetown University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ruth He, Assistant Professor of Medicine, Georgetown University Identifier: NCT01205828    
Other Study ID Numbers: 2009-268
First Posted: September 21, 2010    Key Record Dates
Results First Posted: April 1, 2016
Last Update Posted: April 11, 2017
Last Verified: January 2017
Keywords provided by Ruth He, Georgetown University:
liver cancer
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors