NCT01807156

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 22, 2016

Completed
Last Updated

April 22, 2016

Status Verified

March 1, 2016

Enrollment Period

1.9 years

First QC Date

March 6, 2013

Results QC Date

February 19, 2016

Last Update Submit

March 22, 2016

Conditions

Hepatocellular Cancer

Keywords

TivozanibAdvanced hepatocellular cancerAngiogenesis

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Advanced Hepatocellular Cancer (HCC) Receiving Tivozanib Who Are Free From Progression

    Evaluation of disease progression in the patients with advanced hepatocellular cancer (HCC) receiving tivozanib will be made using CT or MRI scan of the organ(s) with the target lesion(s). Response Evaluation Criteria In Solid Tumors (RECIST) criteria 1.1 will be used for objective tumor response assessment. Measurable lesions can be measured in at least one dimension as ≥ 20 mm with conventional CT scan techniques or as ≥ 10 mm with spiral CT scan. Target lesions are 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.

    6 Months

Secondary Outcomes (1)

  • Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

    6 months

Study Arms (1)

Tivozanib

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.

Drug: Tivozanib

Interventions

TivozanibDRUG

Oral medication given daily. No placebo.

Also known as: AV-951
Tivozanib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with mixed histology or fibrolamellar variant.
  • Prior systemic therapy for metastatic disease.
  • Uncontrolled hypertension (HTN).
  • Symptomatic heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University, Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

tivozanib

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Results Point of Contact

Title
Bassel El-Rayes, MD
Organization
Emory University
bassel.el-rayes@emoryhealthcare.org
404-778-1900

Study Officials

  • Bassel El-Rayes, MD

    Emory University Winship Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

March 6, 2013

First Posted

March 8, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

April 22, 2016

Results First Posted

April 22, 2016

Record last verified: 2016-03

Locations

US(1)