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

Completed · Phase 2

Conditions studied: Advanced Hepatocellular Carcinoma

In brief

Key facts

Study ID: NCT00517920
Run by: AbbVie (prior sponsor, Abbott)
People needed: 44
Starts: 2007-09-01
Expected to finish: 2012-06-01
Last updated by the study team: 2013-01-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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