Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma

This study is ongoing, but not recruiting participants.
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 20, 2016
Last verified: July 2016
  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 ]

Enrollment: 45
Study Start Date: April 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (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   (Adult, Senior)
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

Locations
Taiwan
National Taiwan University Hospital
Taipei City, Taiwan, 100
Taipei Veterans General Hospital
Taipei City, Taiwan, 11217
Tri-Service General Hospital
Taipei City, Taiwan, 114
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

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 20, 2016
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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Axitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 27, 2016