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

AbbVie

Status and phase

Completed

Phase 2

Conditions

Advanced Hepatocellular Carcinoma

Treatments

Drug: ABT-869

Study type

Interventional

Funder types

Industry

Identifiers

M06-879

Details and patient eligibility

About

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

Full description

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

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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