Suspended

Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer

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What is being tested

Tivozanib

Drug
Who is being recruted

Digestive System Diseases+3

+ Digestive System Neoplasms

+ Liver Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorEmory University
Last updated: April 22, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01807156
Principal SponsorEmory University
Last updated: April 22, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

7 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsLiver DiseasesNeoplasmsNeoplasms by SiteLiver Neoplasms

Criteria

Inclusion Criteria: Patients with measurable, histological diagnosis of hepatocellular carcinoma (HCC) and whose disease is not amenable to surgical or regional therapy. Prior allowed therapy: Surgery including hepatic resection Minimum of 4 weeks since any surgical procedure. Patients must have adequately recovered from surgery. Regional therapy Includes transarterial chemoembolization (TACE), drug-eluting bead [DEB]-TACE, percutaneous ethanol injection, radiofrequency/cryo ablation, Yttrium-90 radioembolization. More than 2 weeks must have lapsed from therapy. 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. 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. Adequate hematological, liver and metabolic organ function. Signed informed consent. Exclusion Criteria: Patients with mixed histology or fibrolamellar variant. Prior systemic therapy for metastatic disease. Uncontrolled hypertension (HTN). Symptomatic heart failure.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Emory University, Winship Cancer Institute

Atlanta, United StatesOpen Emory University, Winship Cancer Institute in Google Maps
SuspendedOne Study Center