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COMPLETEDPhase 2NCT00517920

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

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

Lead sponsor: AbbVie (prior sponsor, Abbott)•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

AbbVie (prior sponsor, Abbott)

Collaborators

Genentech, Inc.

An Open-label, Phase 2 study of efficacy and tolerability of ABT-869 in advanced hepatocellular carcinoma (HCC)

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 4, 2013Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment44

Start dateSep 2007

Last updatedJan 4, 2013

Condition

Advanced Hepatocellular Carcinoma

Locations shown

Site Reference ID/Investigator# 7726

Philadelphia, Pennsylvania

Site Reference ID/Investigator# 7169

Toronto

Site Reference ID/Investigator# 5837

Vancouver

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 4, 2013Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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