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Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
AG-013736
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring HCC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Tri-Service General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Axitinib

Arm Description

Outcomes

Primary Outcome Measures

disease stabilization

Secondary Outcome Measures

time-to-tumor progression

Full Information

First Posted
January 6, 2011
Last Updated
February 7, 2017
Sponsor
National Taiwan University Hospital
Collaborators
Tri-Service General Hospital, Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01273662
Brief Title
Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma
Official Title
Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Tri-Service General Hospital, Taipei Veterans General Hospital, Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
HCC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Axitinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AG-013736
Other Intervention Name(s)
Axitinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
disease stabilization
Time Frame
8 weeks until tumor progression
Secondary Outcome Measure Information:
Title
time-to-tumor progression
Time Frame
8 weeks until tumor progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann-Lii Cheng, MD, PhD
Organizational Affiliation
Director/Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei City
ZIP/Postal Code
114
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma

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