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Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma

NCT ID: NCT01334112

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2018-03-31

Brief Summary

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

Detailed Description

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This is a phase II study of an investigational drug, Axitinib following prior antiangiogenic therapy in patients with advanced hepatocellular carcinoma. Hepatocellular carcinoma (HCC) is a primary cancer of the liver. Angiogenesis is a physiological process involving the growth of new blood vessels from pre-existing vessels. A tyrosine kinase is an enzyme that can inhibit angiogenesis. In this study, patients with advanced HCC who have failed prior antiangiogenic therapy, will receive Axitinib in cycles of 4 weeks. Axitinib is an oral, potent and selective inhibitor of angiogenesis. This study will evaluate the response rate of HCC following treatment with Axitinib as well as safety, feasibility, overall survival of patients, progression-free survival, and quality of life in persons with unresectable HCC. The study also compares response determined by RECIST to response determined by Choi Criteria.

Conditions

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Hepatocellular Carcinoma

Keywords

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Hepatocellular Carcinoma Advanced Hepatocellular Carcinoma Liver Cancer Axitinib AG-013736

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Axitinib

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

Group Type EXPERIMENTAL

Axitinib (AG-013736)

Intervention Type DRUG

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

Interventions

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Axitinib (AG-013736)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Knox, MSc, FRCPC, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Princess Margaret Hospital

Kelly Burak, MD, FRCPC, BSc, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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Foothills Hospital, Alberta Health Services

Calgary, Alberta, Canada

Site Status

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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WS515376

Identifier Type: -

Identifier Source: org_study_id