ABT-888 and Temozolomide for Liver Cancer

NCT ID: NCT01205828

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-10-31

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.

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).

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days

ABT-888

Intervention Type: DRUG

ABT-888 40 mg BID PO Days 1-7 every 28 days

Interventions

Temozolomide

Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days

Intervention Type: DRUG

ABT-888

ABT-888 40 mg BID PO Days 1-7 every 28 days

Intervention Type: DRUG

Other Intervention Names

Temodar; Veliparib

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aiwu R He, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26449224 (View on PubMed)

Other Identifiers

2009-268

Identifier Type: -

Identifier Source: org_study_id