Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer
The purpose of this study is to learn about the effect of the investigational agent tivozanib on the control of the tumor growth in hepatocellular (liver) cancer. The investigators also plan to collect information on the likelihood to develop side effects while on this treatment. Tivozanib is an oral medication (pill) taken once a day. This medication is designed to stop the tumor from developing new blood vessels.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer|
- Number of patients with advanced HCC (hepatocellular cancer) receiving tivozanib who are free the proportion of patients with advanced HCC receiving tivozanib who are free from progression [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]Evaluation of disease progression will be made using CT or MRI scan of the organ(s) with the target lesion(s).
- Response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Measurable lesions: Lesions that can be measured in at least one dimension as ≥ 20 mm with conventional CT scan techniques or as ≥ 10 mm with spiral CT scan.
Non-measurable lesions: All other lesions including small lesions (longest diameter < 20 mm with conventional techniques) and other non-measurable lesions including: pleural effusions, ascites, and disease documented by indirect evidence (e.g. biochemical abnormalities).
Target lesions: All measurable lesions up to a maximum of 5 lesions. Target lesions are selected for their size and suitability for accurate repetitive measurements. The sum of the longest diameter of all target lesions will be calculated and reported as the baseline sum longest diameter (LD). This will be used as a reference to further quantify objective response.
Non-target lesions: All other lesions are identified as non-target lesions and should be followed as present or absent.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.
Oral medication given daily. No placebo.
Other Name: AV-951
Angiogenesis is the formation of new blood vessels. Angiogenesis is driven by cytokines including vascular endothelial growth factor. Tivozanib is an oral medication that inhibits vascular endothelial growth factor preventing tumor from developing new blood vessels.
The purpose of this study is to evaluate the effects of tivozanib on hepatocellular (liver) cancer. Participants in the study take tivozanib daily at a dose of 1 mg for 1month. if doing well the dose would be increased to 1.5 mg per day. Patients are monitored for response using CT or MRI scans every 2months. In addition, patients will have blood draws to evaluate the effects of tivozanib on blood vessels.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01807156
|United States, Georgia|
|Emory University, Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Bassel El-Rayes, MD||Emory University Winship Cancer Institute|