Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer

This study is currently recruiting participants.
Verified November 2013 by Emory University
Sponsor:
Information provided by (Responsible Party):
Bassel El-Rayes, Emory University
ClinicalTrials.gov Identifier:
NCT01807156
First received: March 6, 2013
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Hepatocellular Cancer
Drug: Tivozanib
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • Response rate based on 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 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.



Estimated Enrollment: 22
Study Start Date: March 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tivozanib
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.
Drug: Tivozanib
Oral medication given daily. No placebo.
Other Name: AV-951

Detailed Description:

Angiogenesis is the formation of new blood vessels. Angiogenesis is driven by cyokines 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  1. 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.
  2. Adequate hematological, liver and metabolic organ function.
  3. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01807156

Contacts
Contact: Bassel El-Rayes, MD 404-778-3882 belraye@emory.edu
Contact: Syed F Zafar, MD 404-778-1351 sfzafar@emory.edu

Locations
United States, Georgia
Emory University, Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Bassel El-Rayes, MD    404-778-3882    belray@meoy.edu   
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Bassel El-Rayes, MD Emory University Winship Cancer Institute
  More Information

No publications provided

Responsible Party: Bassel El-Rayes, Studu Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01807156     History of Changes
Other Study ID Numbers: IRB00061422, IRB00061422, WINSHIP2302-12
Study First Received: March 6, 2013
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Emory University:
Tivozanib
Advanced hepatocellular cancer
Angiogenesis

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 17, 2014