Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
NCT ID: NCT00517920
Last Updated: 2013-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2007-09-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ABT-869
ABT-869
0.25 mg/kg QD
Interventions
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ABT-869
0.25 mg/kg QD
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Justin Ricker, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 7726
Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 7169
Toronto, , Canada
Site Reference ID/Investigator# 5837
Vancouver, , Canada
Site Reference ID/Investigator# 5235
Singapore, , Singapore
Site Reference ID/Investigator# 5611
Singapore, , Singapore
Site Reference ID/Investigator# 6265
Taipei, , Taiwan
Countries
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Other Identifiers
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M06-879
Identifier Type: -
Identifier Source: org_study_id
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