NCT01273662

Brief Summary

This is a phase II study of axitinib as the second-line on the treatment of advanced hepatocellular carcinoma (HCC). The purpose of this study is a proof-of-concept study to see if axitinib has any anti-tumor effect in HCC. The primary endpoint is disease stabilization that lasts for at least 8 weeks without progression of tumor-related symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

January 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

4.9 years

First QC Date

January 6, 2011

Last Update Submit

February 7, 2017

Conditions

Hepatocellular Carcinoma

Keywords

HCC

Outcome Measures

Primary Outcomes (1)

  • disease stabilization

    8 weeks until tumor progression

Secondary Outcomes (1)

  • time-to-tumor progression

    8 weeks until tumor progression

Study Arms (1)

Axitinib

EXPERIMENTAL
Drug: AG-013736

Interventions

AG-013736DRUG

All enrolled patients will receive axitinib, 5 mg orally twice daily with food, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation by the subjects.

Also known as: Axitinib
Axitinib

Eligibility Criteria

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

You may qualify if:

  • Histologically diagnosed HCC, OR clinically diagnosed HCC
  • Inoperable tumor(s) and no applicable curative therapy. Not amenable to loco-regional therapy
  • Documented progression with or intolerance to sorafenib treatment as first- line therapy for advanced HCC
  • At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure
  • ECOG performance status 0 or 1
  • Life expectancy is at least 2 months
  • Child-Pugh class A liver function.

You may not qualify if:

  • Systemic therapy other than sorafenib as first-line therapy for advanced HCC
  • History of HCC tumor rupture
  • Presence of brain or leptomeningeal metastases
  • Esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding
  • History of upper gastrointestinal bleeding within 1 year
  • Major systemic diseases that the investigator considers inappropriate for participation
  • Uncontrollable hypertension
  • Proteinuria
  • Current use or anticipated need for treatment with potent CYP3A4 inhibitor, CYP3A4 or CYP1A2 inducers
  • Requirement of anticoagulant therapy with oral vitamin K antagonists
  • Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
  • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Axitinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ann-Lii Cheng, MD, PhD

    Director/Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2011

First Posted

January 10, 2011

Study Start

April 1, 2011

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

TW(3)