Study of Axitinib in Patients With Unresectable Hepatocel... | NCT01334112

Studies
Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma

NCT01334112

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Dec 12, 2019Actual

Enrollment

30Actual

Phase

Phase 2

Conditions

Hepatocellular Carcinoma

Interventions

Axitinib (AG-013736)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Mar 2018Actual

Completion Date

Mar 2018Actual

First Submitted Date

Feb 14, 2011

First Submission Date that Met QC Criteria

Apr 11, 2011

First Posted Date

Apr 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2019

Last Update Posted Date

Dec 12, 2019Actual

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Axitinib	Experimental	Oral Axitinib (5mg, twice daily) will be administered to all patients	Drug: Axitinib (AG-013736)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response rate		Response rate assessed by CT scan at 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Feasibility	The ability to administer one or more cycles of Axitinib to >70% of patients at a dose of 5mg po BID	Assessed at the end of stage 1 (10 patients accrued) and at the end of trial (Stage 2, 29 patients total)
Overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jennifer Knox, MSc, FRCPC, MD	University Health Network, Princess Margaret Hospital	Principal Investigator
Kelly Burak, MD, FRCPC, BSc, MSc	University of Calgary	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Foothills Hospital, Alberta Health Services		Calgary	Alberta		Canada
University Health Network, Princess Margaret Hospital

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular
D008113	Liver Neoplasms

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146