NCT01835223

Tivozanib in Treating Patients With Liver Cancer That Is Metastatic or Cannot Be Removed by Surgery

Multicenter Phase 1b/2 Study of Tivozanib in Patients With Advanced Inoperable Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of tivozanib and to see how well it works in treating patients with liver cancer that has spread to other parts of the body or cannot be removed by surgery. Tivozanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. Progression free survival (PFS) at 24 weeks in patients with advanced hepatocellular carcinoma (HCC). SECONDARY OBJECTIVES: I. To determine the safety of tivozanib in HCC. II. To determine the overall survival (OS) and clinical benefit rate (complete response \[CR\], partial response \[PR\] and stable disease \[SD\]) by Response Evaluation Criteria in Solid Tumors (RECIST). III. To determine the steady state pharmacokinetics (PK) and soluble vascular endothelial growth factor receptor 2 (VEGFR-2) baseline/change with tivozanib and use modeling to correlate exposure with biomarker change and the primary outcome measure of PFS. IV. To determine the change in viral load (hepatitis B virus \[HBV\] and hepatitis C virus \[HCV\]) during therapy in patients with HBV or HCV associated HCC. V. To determine the change in tumor marker (alfa fetoprotein) with tivozanib therapy is in the effect of tivozanib on several tumor-associated immune response markers. OUTLINE: This is a phase I, dose-escalation study followed by a phase II study. Patients receive tivozanib orally (PO) once daily (QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months.

Conditions

• Advanced Adult Hepatocellular Carcinoma
• Non-Resectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Tivozanib (1mg)	Given PO
DRUG	Tivozanib (1.5mg)	Given PO

Timeline

• Start date: 2013-07-11
• Primary completion: 2018-12-24
• Completion: 2019-11-08
• First posted: 2013-04-18
• Last updated: 2020-10-28
• Results posted: 2020-10-28

Locations

2 sites across 1 country: United States