Advanced Hepatocellular Carcinoma
Conditions
Brief summary
Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
Detailed description
An Open-label, Phase 2 study of efficacy and tolerability of ABT-869 in advanced hepatocellular carcinoma (HCC)
Interventions
DRUGABT-869
0.25 mg/kg QD
Sponsors
Genentech, Inc.
AbbVie (prior sponsor, Abbott)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Rate | Week 16 |
| Objective Response Rate | Week 16 |
Countries
Canada, Singapore, Taiwan, United States
Outcome results
None listed