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Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Cancer

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Trial Information

Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

Evaluation of disease progression will be made using CT or MRI scan of the organ(s) with the target lesion(s).

Outcome Time Frame:

6 Months

Safety Issue:

Yes

Principal Investigator

Bassel El-Rayes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

WINSHIP2302-12

NCT ID:

NCT01807156

Start Date:

March 2013

Completion Date:

March 2016

Related Keywords:

  • Hepatocellular Cancer
  • Tivozanib
  • Advanced hepatocellular cancer
  • Angiogenesis
  • Liver Neoplasms

Name

Location
Emory University, Winship Cancer Institute Atlanta, Georgia  30322