Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)

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: NCT00517920
Recruitment Status : Completed
First Posted : August 17, 2007
Last Update Posted : January 4, 2013
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

August 16, 2007
August 17, 2007
January 4, 2013
September 2007
June 2011   (Final data collection date for primary outcome measure)
  • Progression-Free Rate [ Time Frame: Week 16 ]
  • Objective Response Rate [ Time Frame: Week 16 ]
Progression-Free Rate [ Time Frame: Week 16 ]
Complete list of historical versions of study NCT00517920 on Archive Site
Not Provided
Objective Response Rate [ Time Frame: Week 16 ]
Not Provided
Not Provided
Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
An Open-Label, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
An Open-label, Phase 2 study of efficacy and tolerability of ABT-869 in advanced hepatocellular carcinoma (HCC)
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Hepatocellular Carcinoma
Drug: ABT-869
0.25 mg/kg QD
Experimental: ABT-869
Intervention: Drug: ABT-869
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2012
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria

  • Subject must be greater than or equal to 18 years of age
  • Subject must be diagnosed with unresectable or metastatic HCC
  • Subjects must have a measurable lesion by RECIST on CT scan in at least one site which has not received radiation
  • Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
  • No other active malignancy within the past 5 years

Exclusion Criteria

  • Subject has received targeted VEGF/PDGF/TKI therapy. Prior Avastin is allowed
  • Subject has Child-Pugh grade Class C hepatic impairment
  • The subject has proteinuria Common Toxicity Criteria (CTC) grade > 1 as measured by routine urinalysis or 24 hour urine collection during screening assessment
  • Subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention
  • The subject has a documented left ventricular Ejection Fraction < 50%
  • Subject is receiving therapeutic anticoagulation therapy
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   Singapore,   Taiwan,   United States
China,   Hong Kong
Not Provided
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Genentech, Inc.
Study Director: Justin Ricker, MD AbbVie
January 2013

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