A Safety, Tolerability, and Pharmacokinetics Study of Onartuzumab as Single Agent or in Combination With Sorafenib in Participants With Advanced Hepatocellular Carcinoma
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Cytologically or histologically confirmed diagnosis of hepatocellular carcinoma (HCC)
Advanced or metastatic disease
Not a candidate for curative treatments (that is, resection, transplantation)
Child-Pugh class A liver function
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Life expectancy greater than (\>) 3 months
For participants who received prior adjuvant chemotherapy, a treatment-free interval of at least 6 months between the last chemotherapy cycle and Cycle 1 Day 1
You may not be if
Prior surgery or local therapy within 4 weeks prior to Cycle 1 Day 1, with the exception of palliative radiation therapy to the bone
Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation
Granulocyte count less than (\<) 1500 per cubic millimeter (mm\^3), platelet count \< 75,000/mm\^3, and hemoglobin \< 8 gram per deciliter (g/dL) within 7 days prior to Cycle 1 Day 1
Total bilirubin greater than (\>) 1.5 times the upper limit of normal (ULN)
Serum creatinine \> 1.5 × ULN or creatinine clearance \< 60 cubic centimeter per minute (cc/min) by Cockcroft-Gault formula
Significant history of cardiac disease within 6 months prior to Cycle 1 Day 1, myocardial infarction within the previous year, or current cardiac ventricular arrhythmias requiring medication
Serious active infection, or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment, with the exception of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections
Known active infection with human immunodeficiency virus (HIV) or known HIV-seropositivity
Inability to take oral medication or untreated malabsorption syndrome
Pregnant or lactating women
History of transplantation including organ, bone marrow transplantation, and peripheral blood stem cell transplantation with the exception of corneal transplantation
Active bleeding diathesis (including active esophageal varices) or tumor rupture within 8 weeks prior to Cycle 1 Day1 that are not successfully treated
Uncontrolled hypertension
Treatment with any other investigational drug within 4 weeks of Cycle 1 Day
