NCT01334112

Brief Summary

The purpose of this study is to evaluate the potential role of Axitinib (AG-013736) in the treatment of unresectable/metastatic hepatocellular carcinoma (HCC)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 12, 2011

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

7.2 years

First QC Date

February 14, 2011

Last Update Submit

December 11, 2019

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaAdvanced Hepatocellular CarcinomaLiver CancerAxitinibAG-013736

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Response rate assessed by CT scan at 16 weeks

Secondary Outcomes (7)

  • Feasibility

    Assessed at the end of stage 1 (10 patients accrued) and at the end of trial (Stage 2, 29 patients total)

  • Overall survival

    At the completion of trial, 1.5 years

  • Response rate comparison

    Comparison of outcomes with RECIST criteria to Choi criteria and changes to perfusion on DCE ultrasound will occur at the end of stage 1 (after accrual of 10 patients) and trial completion

  • Progression-free survival

    At trial completion, 1.5 years

  • Quality of life

    At completion of trial, 1.5 years

  • +2 more secondary outcomes

Study Arms (1)

Axitinib

EXPERIMENTAL

Oral Axitinib (5mg, twice daily) will be administered to all patients

Drug: Axitinib (AG-013736)

Interventions

Axitinib (AG-013736)DRUG

5mg, oral, twice daily, continuous dosing. A dosing cycle is defined as 4 weeks. Treatment may continue until disease progression/relapse

Axitinib

Eligibility Criteria

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

You may qualify if:

  • Unresectable and/or metastatic Hepatocellular Carcinoma
  • Previous treatment with tyrosine kinase inhibitors or antiangiogenic drugs
  • Life expectancy of ≥12 weeks
  • At least one tumor lesion
  • At least 2 weeks since the end of prior systemic treatment
  • No evidence of pre-existing uncontrolled hypertension
  • ECOG 0 or 1
  • Adequate organ function
  • Not appropriate for curative therapy
  • Child A or B7 cirrhosis
  • CLIP score ≤ 4

You may not qualify if:

  • Received any other systemic therapy for Hepatocellular Carcinoma within 2 weeks prior to treatment
  • Major surgery \<4 weeks or radiation therapy \<2 weeks of starting the study treatment
  • Previous or concurrent cancer that is distinct in primary site or histology from Hepatocellular Carcinoma
  • Severe acute or chronic medical or psychiatric condition
  • Need for treatment with prohibited drugs
  • Has received local therapy to all measurable lesions
  • Stage B8 or higher liver cirrhosis
  • Ascites refractory to diuretic therapy
  • Clinically significant ECG abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Foothills Hospital, Alberta Health Services

Calgary, Alberta, Canada

Location

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Interventions

Axitinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive 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

  • Jennifer Knox, MSc, FRCPC, MD

    University Health Network, Princess Margaret Hospital

    PRINCIPAL INVESTIGATOR

  • Kelly Burak, MD, FRCPC, BSc, MSc

    University of Calgary

    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

February 14, 2011

First Posted

April 12, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

December 12, 2019

Record last verified: 2019-12

Locations

CA(2)