Status:
COMPLETED
A Safety, Tolerability, and Pharmacokinetics Study of Onartuzumab as Single Agent or in Combination With Sorafenib in Participants With Advanced Hepatocellular Carcinoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This multicenter, open-label study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities of onartuzumab as single agent or in combination with sorafenib in participants with adva...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT), Alanine transaminase (ALT) serum glutamic-pyruvic transaminase (SGPT), alkaline phosphatase (ALP) \> 5 × 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01897038
Start Date
September 1 2013
End Date
March 1 2015
Last Update
November 2 2016
Active Locations (10)
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1
Sarasota, Florida, United States, 34232
2
Baltimore, Maryland, United States, 21231
3
New York, New York, United States, 10065
4
Nashville, Tennessee, United States, 37203