Hepatocellular Carcinoma Non-resectable, Hepatocellular Carcinoma Recurrent, Carcinoma, Hepatocellular, Liver Diseases, Neoplasms by Histologic Type, Digestive System Neoplasms, Carcinoma, Liver Neoplasms, Neoplasms, Neoplasms by Site, Digestive System Diseases, Adenocarcinoma, Neoplasms, Glandular and Epithelial
Conditions
Keywords
Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Growth Substances, Physiological Effects of Drugs, Enzyme Inhibitors, Angiogenesis Inhibitors, Inhibitors, Angiogenesis, Protein Kinase Inhibitors, Pharmacologic Actions, Growth Inhibitors, Angiogenesis Modulating Agents, Sorafenib
Brief summary
The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC.
Detailed description
The IDMC recommended discontinuation of the study, and, the protocol was amended to end study treatment.
Interventions
DRUGABT-869
Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity
DRUGSorafenib
Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic or cytologic diagnosis with unresectable or metastatic HCC * Child Pugh Class A * ECOG performance status 0-1 * Adequate hematologic, hepatic, and renal function
Exclusion criteria
* Prior systemic (administered intravenously or orally rather than locoregionally) treatment for HCC * Prior local therapy (including liver-directed therapy) within 4 weeks from entry * Untreated brain or meningeal metastases * Current treatment on another clinical trial * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | From randomization until patient death; assessed monthly |
Secondary
| Measure | Time frame |
|---|---|
| Time To Progression (TTP) | From randomization until patient progression; assessed every 6 weeks |
| Overall Response Rate (ORR) | Assessed Every 6 weeks |
Countries
Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czechia, Denmark, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Puerto Rico, Romania, Russia, Singapore, South Korea, Spain, Taiwan, United States
Outcome results
None listed