Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer

Hepatocellular Cancer Clinical Trial

Official title:

Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01807156
• Other study ID #: IRB00061422
• Secondary ID: IRB00061422WINSH
• Status: Terminated
• Phase: Phase 2
• First received: March 6, 2013
• Last updated: March 3, 2015
• Start date: March 2013
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with measurable, histological diagnosis of HCC and whose disease is not amenable to surgical or regional therapy.

2. Prior allowed therapy:

• Surgery including hepatic resection

1. Minimum of 4 weeks since any surgical procedure.

2. Patients must have adequately recovered from surgery.

• Regional therapy

1. Includes transarterial chemoembolization (TACE, DEB-TACE), percutaneous ethanol injection, radiofrequency/cryo ablation, Yttrium-90 radioembolization.

2. More than 2 weeks must have lapsed from therapy.

3. There must be an indicator lesion outside the treated area or clear evidence of progression in the treated lesion, not amenable for further local therapies.

4. Concomitant sorafenib with regional therapy is allowed as long as no evidence of progression on sorafenib.

• Prior adjuvant sorafenib is allowed, if completed more than 6 months prior to disease recurrence.

3. Adequate hematological, liver and metabolic organ function.

4. Signed informed consent.

Exclusion Criteria:

1. Patients with mixed histology or fibrolamellar variant.

2. Prior systemic therapy for metastatic disease.

3. Uncontrolled hypertension (HTN).

4. Symptomatic heart failure.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatocellular Cancer
• Liver Neoplasms

Intervention

Drug:
• Tivozanib
Oral medication given daily. No placebo.

Locations

Country	Name	City	State
United States	Emory University, Winship Cancer Institute	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	AVEO Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with advanced hepatocellular cancer (HCC) receiving tivozanib who are free the proportion of patients with advanced HCC receiving tivozanib who are free from progression	Evaluation of disease progression will be made using CT or MRI scan of the organ(s) with the target lesion(s).	6 Months	Yes
Secondary	Response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria	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.	6 months	Yes