ABT-888 and Temozolomide for Liver Cancer

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01205828
• Other study ID #: 2009-268
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 18, 2010
• Last updated: February 4, 2014
• Start date: August 2010
• Est. completion date: July 2014

Study information

• Verified date: February 2014
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: July 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• temozolomide + 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).

Locations

Country	Name	City	State
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical benefit rate	complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria	1 year	No
Secondary	overall survival	the number of days between a patient's enrollment and his/her date of death	2 years	No
Secondary	Progression free survival	The number of days between a patient's enrollment and his/her disease progression	2 years	No
Secondary	Safety assessment	Record of all toxicities graded according to the NCI CTCAE version 3.0	6 months	Yes
Secondary	Biomarker analysis	Markers in blood or tissue that are looked at will be classified as yes (present)or no (not present)	2 months	No