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Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Taiwan University Hospital
Sponsor:
Collaborators:
Tri-Service General Hospital
Taipei Veterans General Hospital, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01273662
First received: January 6, 2011
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: AG-013736
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • disease stabilization [ Time Frame: 8 weeks until tumor progression ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • time-to-tumor progression [ Time Frame: 8 weeks until tumor progression ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Axitinib Drug: AG-013736
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.
Other Name: Axitinib

Detailed Description:

Axitinib can can inhibit the activity of multiple angiogenesis-related signaling pathways. Promising anti-tumor activity has been demonstrated in patients with renal cell carcinoma, thyroid cancer, and melanoma. The potent anti-angiogenic activity of axitinib makes it a promising agent for the treatment of HCC.

This is a single-arm, open-label phase II trial. Eligible patients will receive axitinib, starting at 5 mg orally twice daily in the fasting status, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation. Dose titration will be done according to the severity of adverse events.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273662

Contacts
Contact: Ann-Lii Cheng, MD, PhD 886-2-23123456 ext 67251 alcheng@ntu.edu.tw
Contact: Chiun Hsu, MD, PhD 886-2-23123456 ext 67009 chsu1967@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei City, Taiwan, 100
Contact: Ann-Lii Cheng, MD,PhD    886-2-23123456 ext 67251    alcheng@ntu.edu.tw   
Contact: Chiun Hsu, MD, PhD    886-2-23123456 ext 67009    chsu1967@ntu.edu.tw   
Principal Investigator: Ann-Lii Cheng, MD, PhD         
Sub-Investigator: Chiun Hsu, MD, PhD         
Sub-Investigator: Chih-Hung Hsu, MD, PhD         
Sub-Investigator: Zhong-Zhe Lin, MD         
Sub-Investigator: Ying-Chun Shen, MD         
Sub-Investigator: Ting-Fang Shih, MD         
Taipei Veterans General Hospital Recruiting
Taipei City, Taiwan, 11217
Contact: Yee Chao, MD, PhD    886-2-28757270 ext 7618    ychao@vghtpe.gov.tw   
Principal Investigator: Yee Chao, MD, PhD         
Tri-Service General Hospital Recruiting
Taipei City, Taiwan, 114
Contact: Yeu-Chin Chen, MD    886-2-87927208    yeuchin99@gmail.com   
Principal Investigator: Yeu-Chin Chen, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Tri-Service General Hospital
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Ann-Lii Cheng, MD, PhD Director/Professor
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01273662     History of Changes
Other Study ID Numbers: 201008013M
Study First Received: January 6, 2011
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration
Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
HCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Axitinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014