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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


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
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