Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma

NCT01334112

Last updated date
Study Location
Foothills Hospital, Alberta Health Services
Calgary, Alberta, , Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatocellular Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma
Official Title  ICMJE A Phase II Trial of Axitinib (AG-013736) After Prior Antiangiogenic Therapy in Advanced Hepatocellular Carcinoma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE Drug: Axitinib (AG-013736)
5mg, oral, twice daily, continuous dosing. A dosing cycle is defined as 4 weeks. Treatment may continue until disease progression/relapse
Study Arms  ICMJE Experimental: Axitinib
Oral Axitinib (5mg, twice daily) will be administered to all patients
Intervention: Drug: Axitinib (AG-013736)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2018)
30
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2011)
29
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01334112
Other Study ID Numbers  ICMJE WS515376
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Jennifer Knox, MSc, FRCPC, MDUniversity Health Network, Princess Margaret Hospital
Principal Investigator:Kelly Burak, MD, FRCPC, BSc, MScUniversity of Calgary
PRS Account University Health Network, Toronto
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP