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Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma

This study is currently recruiting participants.
Verified April 2013 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: May 1, 2013
Last verified: April 2013
History of Changes

January 6, 2011
May 1, 2013
April 2011
December 2013   (final data collection date for primary outcome measure)
disease stabilization [ Time Frame: 8 weeks until tumor progression ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01273662 on ClinicalTrials.gov Archive Site
time-to-tumor progression [ Time Frame: 8 weeks until tumor progression ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma
Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma

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.

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.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
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
Experimental: Axitinib
Intervention: Drug: AG-013736
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Taiwan
 
NCT01273662
201008013M
No
National Taiwan University Hospital
National Taiwan University Hospital
  • Tri-Service General Hospital
  • Taipei Veterans General Hospital,Taiwan
Principal Investigator: Ann-Lii Cheng, MD, PhD Director/Professor
National Taiwan University Hospital
April 2013

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