A Safety, Tolerability, and Pharmacokinetics Study of Onartuzumab as Single Agent or in Combination With Sorafenib in Participants With Advanced Hepatocellular Carcinoma
Completed · Phase 1
Conditions studied: Carcinoma, Hepatocellular
In brief
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 advanced hepatocellular carcinoma. Participants in Cohort 1 will receive onartuzumab as single agent on Day 1 of each 21-day cycle. Participants in Cohorts 2 or 3 will receive onartuzumab on Day 1 of each 21-day cycle in combination with sorafenib 400 mg orally daily or twice daily. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Key facts
- Study ID
- NCT01897038
- Run by
- Hoffmann-La Roche
- People needed
- 9
- Starts
- 2013-09-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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)
- 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
Where it is running
- Study site — Sarasota, Florida, United States
- Study site — Baltimore, Maryland, United States
- Study site — New York, New York, United States
- Study site — Nashville, Tennessee, United States
- Study site — Houston, Texas, United States
- Study site — Pokfulam, Hong Kong
- Study site — Singapore, Singapore
- Study site — Singapore, Singapore
- Study site — Tainan, Taiwan
- Study site — Taipei, Taiwan
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.