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ABT-888 and Temozolomide for Liver Cancer

This study is currently recruiting participants.
Verified October 2011 by Georgetown University
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Ruth He, Georgetown University
ClinicalTrials.gov Identifier:
NCT01205828
First received: September 18, 2010
Last updated: October 4, 2011
Last verified: October 2011
History of Changes

September 18, 2010
October 4, 2011
August 2010
December 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01205828 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
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
Experimental: temozolomide + ABT-888
Temozolomide and ABT-888
Intervention: Drug: temozolomide + ABT-888
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
49
December 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Erin Sandene, BSN 202-687-2007 eks43@georgetown.edu
Contact: Lisa Ley, MSN 202-687-6653 leyl@georgetown.edu
United States
 
NCT01205828
2009-268
Yes
Ruth He, Georgetown University
Georgetown University
Abbott
Principal Investigator: Aiwu R He, MD PhD Georgetown University
Georgetown University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP