ABT-888 and Temozolomide for Liver Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Ruth He, Georgetown University
ClinicalTrials.gov Identifier:
NCT01205828
First received: September 18, 2010
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Hepatocellular Carcinoma
Drug: temozolomide + ABT-888
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • clinical benefit rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria


Secondary Outcome Measures:
  • overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    the number of days between a patient's enrollment and his/her date of death

  • Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The number of days between a patient's enrollment and his/her disease progression

  • Safety assessment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Record of all toxicities graded according to the NCI CTCAE version 3.0

  • Biomarker analysis [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Markers in blood or tissue that are looked at will be classified as yes (present)or no (not present)


Estimated Enrollment: 49
Study Start Date: August 2010
Estimated Study Completion Date: July 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: temozolomide + ABT-888
Temozolomide and ABT-888
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).

Other Names:
  • ABT-888
  • Temozolomide
  • Temodar
  • TMZ

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205828

Locations
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
Abbott
Investigators
Principal Investigator: Aiwu R He, MD PhD Georgetown University
  More Information

No publications provided

Responsible Party: Ruth He, Assistant Professor of Medicine, Georgetown University
ClinicalTrials.gov Identifier: NCT01205828     History of Changes
Other Study ID Numbers: 2009-268
Study First Received: September 18, 2010
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgetown University:
liver cancer
hepatocellular
temozolomide
veliparib

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014