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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00517920
First received: August 16, 2007
Last updated: January 2, 2013
Last verified: January 2013
History of Changes

August 16, 2007
January 2, 2013
September 2007
June 2011   (final data collection date for primary outcome measure)
  • Progression-Free Rate [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Progression-Free Rate [ Time Frame: Week 16 ]
Complete list of historical versions of study NCT00517920 on ClinicalTrials.gov 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)
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Singapore,   Taiwan
 
NCT00517920
M06-879
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Genentech
Study Director: Justin Ricker, MD AbbVie
AbbVie
January 2013

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